Endo Pharmaceuticals / Par Pharmaceutical
Description Job Summary - a concise overview of the jobThe QC Analyst III – Microbiology will perform microbiological testing, release of in-process, intermediates and finished products and testing for validation purposes. This role is responsible for reviewing data for compliance specifications, reporting abnormalities to senior management with solution recommendations. Additionally, the QC Analyst III – Microbiology will prepare documentation for presentation to Regulatory Agencies. This role also assists and trains less senior QC Analysts with technical writing. All incumbents are responsible for following applicable Division & Company policies and procedures.Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&L responsibility, etc.Quality Control (QC) Microbiology Department. Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of timeAccountabilityResponsibilities% of TimeSample Collection & Testing§ Conducts routine and non-routine analysis of environmental samples, raw materials, in process, and finished products according to standard operating procedures (SOPs).§ Adheres to Company safety procedures and guidelines on a daily basis.40%Technical Support§ Acts as technical liaison between QC and outside departments or contractors / subsidiaries.15%Documentation§ Completes appropriate documentation to support testing procedures including data capture forms, equipment logbooks, and inventory forms.15%Instrument Maintenance§ Calibrates and maintains laboratory equipment according to SOPs.§ Identifies and troubleshoots equipment problems with solution recommendations.5%Data Review§ Reviews data obtained for compliance to specifications and reports abnormalities to QC management with solution recommendations.5%Technical Writing§ Authors new SOPs and/or revises existing documentation.§ Writes Deviation Investigations (DI’s), Laboratory Assessments (LA’s), and Investigation Reports (IR’s).§ Prepares documentation for presentation to Regulatory Agencies.§ Assists and trains less senior QC Analysts with technical writing.5%GMP Compliance§ Applies knowledge of Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs) on a daily basis.5%Validation§ Prepares validation protocols, executes experiments, and prepares validation reports.5%Other Tasks§ Other duties as assigned by QC management.5%Total100% QualificationsEducation & ExperienceMinimal acceptable level of education, work experience and certifications required for the job§ B.S. in a Biological Science or related field with a minimum of 5-7 years’ experience in pharmaceutical or biotechnology industry required OR§ M.S. in a Biological Science or related field with a minimum of 3+ years’ experience in pharmaceutical or biotechnology industry.§ Microbiology testing experience in a pharmaceutical or biotechnology industry required.§ General experience in a development, quality, or manufacturing environment preferred.KnowledgeProficiency in a body of information required for the job e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.§ Deep knowledge of microbiology testing (i.e., USP Purified Water, WFI, Nitrogen, Compressed Air, Environmental Monitoring, bioburden, endotoxin, TOC).§ Deep knowledge of cGMP practices, ICH requirements, stability, and validation.Skills&AbilitiesOften referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc.§ Applies critical thought to solving problems of complex scope.§ Works on complex problems requiring an in-depth knowledge of scientific methods and techniques.§ Strong verbal and communication skills required.§ Proficient in common software applications.§ Ability to handle multiple priorities in a fast paced environment.§ Demonstrates excellent interpersonal skills and flexibility.§ Understanding of basic statistical analysis and familiarity with the use of databases is desirable.§ Advanced writing skills.§ Adept in running a great number of methods.§ Apply acquired biopharmaceutical skills to project and assignments.Physical RequirementsPhysical & mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.§ Lifting up to 40 lbs.§ Able to climb ladder for sampling.§ Able to stand for extended periods of time.§ Ability to wear a sterile gown and don shoe covers on a periodic basis. Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.
VA North Texas Health Care System
CIDMO aims to work as an integrated team to advance a consistent standard of care; provide reliability through standardization and surveillance; and promote interoperability and seamless care while advancing VHA as a high-reliability organization focused on patient needs and provider outcomes. CIDMO Supports a high-reliability, learning organization and incorporates new business practices to improve value to Veterans and those who care for them. Provides expertise, education, and new tools in the areas of Health Informatics, Clinical Informatics and Data Management and Analysis.
Major duties include:
Performing analysis of complex requirements and resource allocation problems using mathematical, statistical, or advance modeling techniques to support the organization;
Development, evaluation, coordination, and reporting of multidiscipline assessments;
Utilizes advanced quantitative analytical techniques and methodologies, such as regression analysis, mathematical programming, modeling and automated tools;
Conducts special or quick reaction studies or participates as a team leader in the evaluation and conduct of analytic studies and projects involving broad and varied subject matters monitoring and evaluating proposed methodologies;
participates in operational performance management and strategic analyses providing expert management and analytical support developing strategy and integration of operational planning and activity;
Provide organization development intervention, including coaching, consultation, and facilitation to managers and staff at all levels in the organization;
Review, advise on, and conduct complex analyses, evaluations, or investigations in support of organizational programs, systems, and processes;
Prepares comprehensive technical reports embodying the results of significant aspects of studies conducted or reviewed;
Participate in the preparation of short- and long-range planning guidance in accordance with broad program policies and objectives;
Interprets and promulgates policies and regulations related to management functions, programs, and methodologies;
Develop and conduct analytical methods for assessing the decision trade-space amongst competing organizational and or programmatic priorities;
Perform cost estimation and/or analysis of programs and information systems to determine Life Cycle, Cost Estimates (LCCEs), Independent Cost Estimates (ICE), Total
Ownership Costs (TOC) and/or Economic Analysis (EA) for use in Business Case Analysis (BCA), Return on Investment (ROI) calculation, Best Value determination, Risk assessment, Analysis of Alternatives (AOA), and/or program budget development.
Work Schedule: Monday - Friday - 8:00 AM - 4:30 PM
NOTE: THIS POSITION IS VIRTUAL -VIRTUAL EMPLOYMENT MAY BE CONSIDERED FOR A HIGHLY QUALIFIED APPLICANT -LOCATION TO BE DETERMINED AFTER SELECTION
Recruitment & Relocation Incentives: Not authorized
Financial Disclosure Report: Not Required
BASIC REQUIREMENT (TRANSCRIPT REQUIRED): Do you possess a successful completion of a bachelor's Degree (or higher) in operations research; or at least 24 semester hours in a combination of operations research, mathematics, probability, statistics, mathematical logic, science, or subject-matter courses requiring substantial competence in college-level mathematics or statistics. At least 3 of the 24 semester hours must have been in calculus.
In addition to meeting the Basic Requirement, to qualify for this position, you must also meet the following:
This position includes aSelective Placement Factor (skill, knowledge, ability or other worker characteristic basic to - and essential for - satisfactory performance of the job). Selective Placements Factors are a prerequisite to appointment and represent minimum requirements for a position. Applicants who do not meet it are ineligible for further consideration. The Selective Placement Factor for this position is: " Experience in managing all aspects of analysis of alternatives of programs and process improvement initiatives that involve complex technical parameters across Departmental functional boundaries."
EXPERIENCE:possess at least one year of specialized experience equivalent to the next lower grade level (GS-13) in Federal Service that equipped the applicant with the particular knowledge, skills, and abilities to perform successfully the duties of the position, and that is typically in or related to the work of the position to be filled? Specialized experience includes: Analyzes and synthesizes complex data from a wide variety of sources to develop novel and unique concepts through application of analytical techniques in problem areas where policy, doctrine, methods and procedures do not exist and basic assumptions must be formulated and proven; analyzes and synthesizes complex data from a wide variety of sources to develop novel and unique concepts through application of analytical techniques in problem areas where policy, doctrine, methods and procedures do not exist and basic assumptions must be formulated and proven; performs cost estimation and/or analysis of programs and information systems to determine life cycle and independent cost estimates, total ownership costs and/or economic analysis for use in business case analyses, return on investment calculations, best value determinations, risk assessments, and/or program budget development; Performs analysis of complex requirements and resource allocation problems using mathematical, statistical, or advance modeling techniques to support the organization; evaluates and conducts programmatic requirements validation, verification, and correlation initiatives; analyzes, identifies, develops, and assesses research efforts; and applies operations research concepts, principles and practices to perform as a leader in conducting comprehensive and complex studies in a wide range of technical areas. Note: The required experience must be clearly supported by your resume. We will not make assumptions regarding experience. See duties section of the vacancy announcement for detailed responsibilities of this position.
You will be rated on the following Competencies as part of the assessment questionnaire for this position:Data Management
Modeling and Simulation
IMPORTANT: A full year of work is considered to be 35-40 hours of work per week. All experience listed on your resume must include the month and year start/end dates. Part-time experience will be credited on the basis of time actually spent in appropriate activities. Applicants wishing to receive credit for such experience must indicate clearly the nature of their duties and responsibilities in each position and the number of hours a week spent in such employment.
Experience refers to paid and unpaid experience, including volunteer work done through National Service programs (e.g., Peace Corps, AmeriCorps) and other organizations (e.g., professional; philanthropic; religious; spiritual; community; student; social). Volunteer work helps build critical competencies, knowledge, and skills and can provide valuable training and experience that translates directly to paid employment. You will receive credit for all qualifying experience, including volunteer experience.
For more information on these qualification standards, please visit the United States Office of Personnel Management's website at https://www.opm.gov/policy-data-oversight/classification-qualifications/general-schedule-qualification-standards/.
IMPORTANT: A transcript must be submitted with your application if you are basing all or part of your qualifications on education.
There is no educational substitution at this grade level.
NOTE: Only education or degrees recognized by the U.S. Department of Education from accredited colleges, universities, schools, or institutions may be used to qualify for Federal employment. You can verify your education here: http://ope.ed.gov/accreditation/. If you are using foreign education to meet qualification requirements, you must send a Certificate of Foreign Equivalency with your transcript in order to receive credit for that education. For further information, visit: http://www.ed.gov/about/offices/list/ous/international/usnei/us/edlite-visitus-forrecog.html.
Physical Requirements: The work is sedentary. Typically, the employee sits comfortably to do the work, however, there may be
some physical activity such as walking, standing, bending, carrying of light items such as papers and books. Occasionally there may be physical activity requiring lifting boxes of records or other items such as computer equipment. No special physical demands are required to perform the work. The work is primarily sedentary in nature. No special physical demands are required.
THIS IS A VIRTUAL POSITION
Receiving Service Credit for Earning Annual (Vacation) Leave: Federal Employees earn annual leave at a rate (4, 6 or 8 hours per pay period) which is based on the number of years they have served as a Federal employee. VA may offer newly-appointed Federal employee's credit for their job-related non-federal experience or active duty uniformed military service. This credited service can be used in determining the rate at which they earn annual leave. Such credit must be requested and approved prior to the appointment date and is not guaranteed.
Special Employment Consideration: VA encourages persons with disabilities to apply, including those eligible for hiring under 5 CFR 213.3102(u), Schedule A, Appointment of persons with disabilities (i.e., intellectual disabilities, severe physical disabilities, or psychiatric disabilities), and/or disabled veterans with a compensable service-connected disability of 30% or more. For more information on how to apply using this appointment authority via the Selective Placement Coordinator within the office, contact the facility Human Resources Department at (866) 941-6416.
It is the policy of the VA to not deny employment to those that have faced financial hardships or periods of unemployment.
Veterans and Transitioning Service Members: Please visit the VA for Vets site for career-search tools for Veterans seeking employment at VA, career development services for our existing Veterans, and coaching and reintegration support for military service members.
The Interagency Career Transition Assistance Plan (ICTAP) and Career Transition Assistance Plan (CTAP) provide eligible displaced Federal competitive service employees with selection priority over other candidates for competitive service vacancies. To be qualified you must submit appropriate documentation and be found well-qualified (have a final rating of 85 or more before any Veterans preference points) for this vacancy. Information about ICTAP and CTAP eligibility is on OPM's Career Transition Resources website at http://www.opm.gov/policy-data-oversight/workforce-restructuring/employee-guide-to-career-transition/.
This job opportunity announcement may be used to fill additional vacancies.
If you are unable to apply online view the following link for information regarding an Alternate Application.
How You Will Be Evaluated
You will be evaluated for this job based on how well you meet the qualifications above.
IN DESCRIBING YOUR EXPERIENCE, PLEASE BE CLEAR AND SPECIFIC. WE WILL NOT MAKE ASSUMPTIONS REGARDING YOUR EXPERIENCE. If your resume does not support your questionnaire answers, we will not allow credit for your response(s).
Your responses to the assessment questionnaire will be reviewed along with the information provided in your resume and supporting documentation to determine if you are qualified for the position. If, after reviewing your resume and/or supporting documentation, a determination is made that you have inflated your qualifications and or experience, your rating may be lowered and/or you may lose consideration for this position. Please follow all instructions carefully. Errors or omissions may affect your eligibility.
Candidates who apply under All U.S. Citizens announcements will be rated and ranked using Category Rating procedures. Qualified candidates will be assigned to a quality category. The categories are defined as follows:
Best qualified - applicants possessing experience that substantially exceeds the minimum qualifications of the position including all selective factors, and who are highly proficient in all requirements of the job and can perform effectively in the position;
Highly qualified - applicants possessing experience that exceeds the minimum qualifications of the position including all selective factors, and who are proficient in most of the requirements of the job;
Well qualified - applicants possessing experience that meets the minimum qualifications of the position including all selective factors, and who are proficient in some, but not all, of the requirements of the job; and
Qualified - applicants possessing experience and/or education that meets the minimum qualifications of the position including all selective factors.
Application of Veterans' Preference: Category rating and selection procedures place those with veteran's preference above non-preference eligibles within each category. Preference eligible applicants that meet the eligibility and qualification requirements and who have a compensable service-connected disability of at least 10 percent are listed in the highest quality category (except when the position being filled is scientific or professional at the GS-09 grade level or higher).
Background checks and security clearance
Drug test required
IMPORTANT: Please ensure your resume include up-to-date contact information (phone number(s), email address(s), etc.)
To apply for this position, you must provide a complete Application Package which includes:
The following documents are accepted, and may be required if applicable to your eligibility and/or qualifications for this position. Please use this checklist to ensure you have included all documents required for your application, such as a copy of your transcript (if using education to qualify), SF-50's (current/former Federal employees), documentation to support Veterans Preference or ICTAP/CTAP documentation (for displaced Federal employees).
DD-214/ Statement of Service
Disability Letter (VA)
Separation Notice (RIF)
SF-50/ Notification of Personnel Action
Veterans' Preference: When applying for Federal Jobs, eligible Veterans should claim preference for 5pt (TP), 10pt (CP/CPS/XP), or for Sole Survivor Preference (SSP) in the questionnaire. You must provide a legible copy of your DD214(s) which shows dates and character of service (honorable, general, etc.). If you are currently serving on active duty and expect to be released or discharged within 120 days you must submit documentation related to your active duty service which reflects the dates of service, character of service (honorable, general, etc.), and dates of impending separation. Additionally, disabled veterans and others eligible for 10-point preference (such as widows or mothers of eligible Veterans) must also submit an SF-15 "Application for 10 Point Veteran Preference" with required proof as stated on the form. Documentation is required to award preference. For more information on Veterans' Preference, please visit http://www.fedshirevets.gov/job/vetpref/index.aspx.
If you are relying on your education to meet qualification requirements:
Education must be accredited by an accrediting institution recognized by the U.S. Department of Education in order for it to be credited towards qualifications. Therefore, provide only the attendance and/or degrees from schools accredited by accrediting institutions recognized by the U.S. Department of Education.
Failure to provide all of the required information as stated in this vacancy announcement may result in an ineligible rating or may affect the overall rating.
A career with the U.S. Government provides employees with a comprehensive benefits package. As a federal employee, you and your family will have access to a range of benefits that are designed to make your federal career very rewarding. Learn more about federal benefits.
Review our benefits
Eligibility for benefits depends on the type of position you hold and whether your position is full-time, part-time, or intermittent. Contact the hiring agency for more information on the specific benefits offered.
How to Apply
How to Apply
All applicants are encouraged to apply online. To apply for this position, you must complete the questionnaire and submit the documentation specified in the Required Documents section below. The complete application package must be submitted by 11:59 PM (ET) on 11/08/2019 to receive consideration. To preview the questionnaire click https://apply.usastaffing.gov/ViewQuestionnaire/10643424.
To begin, click Apply Online to create a USA JOBS account or log in to your existing account. Follow the prompts to select your USA JOBS resume and/or other supporting documents and complete the occupational questionnaire.
Click Submit My Answers to submit your application package.NOTE: It is your responsibility to ensure your responses and appropriate documentation is submitted prior to the closing date.
To verify your application is complete, log into your USAJobs account, https://my.usajobs.gov/Account/Login, select the Application Status link and then select the more information link for this position. The Application page will display the status of your application, the documentation received and processed, and any correspondence the agency has sent related to this application. Your uploaded documents may take several hours to clear the virus scan process. To return to an incomplete application, log into your USA JOBS account and click Update Application in the vacancy announcement. You must re-select your resume and/or other documents from your USA JOBS account or your application will be incomplete.
NOTE: Participation in the seasonal influenza program is a condition of employment and a requirement for all Department of Veterans Affairs Health Care Personnel (HCP). HCP are individuals who, during the influenza season, work in VHA locations where patients receive care or who come into contact with VA patients as part of their duties. VHA locations include, but are not limited to, VA hospitals and associated clinics, community living centers (CLCs), community-based outpatient clinics (CBOCs), domiciliary units, Vet centers and VA-leased facilities. HCP include all VA licensed and unlicensed, clinical and administrative, paid and unpaid, full- and part-time employees, intermittent employees, fee basis employees, VA contractors, students, researchers, volunteers, and trainees who work at these facilities. HCPs that are unable to receive or otherwise decline a flu shot will be expected to wear a face mask throughout the influenza season.
Agency contact information
VHA National Recruitment Center VHA National Recruitment Center
VHA Service Center - 1
6100 Oak Tree Boulevard
Independence, OH 44131
Learn more about this agency
Once your online application is submitted you will receive a confirmation notification by email. After the vacancy announcement closes, we will review applications per Category Rating procedures to ensure qualification and eligibility requirements are met. After the review is complete, a referral certificate(s) is issued and applicants will be notified of their status by email. Referred applicants will be notified as such and may be contacted directly by the hiring office for an interview. All referred applicants receive a final notification once a selection decision has been made.
You may check the status of your application at any time by logging into your USA Jobs account and clicking on Applications. Information regarding your application status can be found in the USAJobs Help Center.
Fair & Transparent
Fair & Transparent
The Federal hiring process is setup to be fair and transparent. Please read the following guidance.
Equal Employment Opportunity Policy
The United States Government does not discriminate in employment on the basis of race, color, religion, sex (including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, membership in an employee organization, retaliation, parental status, military service, or other non-merit factor.
Equal Employment Opportunity (EEO) for federal employees & job applicants
Reasonable Accommodation Policy
Federal agencies must provide reasonable accommodation to applicants with disabilities where appropriate. Applicants requiring reasonable accommodation for any part of the application process should follow the instructions in the job opportunity announcement. For any part of the remaining hiring process, applicants should contact the hiring agency directly. Determinations on requests for reasonable accommodation will be made on a case-by-case basis.
A reasonable accommodation is any change to a job, the work environment, or the way things are usually done that enables an individual with a disability to apply for a job, perform job duties or receive equal access to job benefits.
Under the Rehabilitation Act of 1973, federal agencies must provide reasonable accommodations when:
An applicant with a disability needs an accommodation to have an equal opportunity to apply for a job.
An employee with a disability needs an accommodation to perform the essential job duties or to gain access to the workplace.
An employee with a disability needs an accommodation to receive equal access to benefits, such as details, training, and office-sponsored events.
You can request a reasonable accommodation at any time during the application or hiring process or while on the job. Requests are considered on a case-by-case basis.
Learn more about disability employment and reasonable accommodations or how to contact an agency.
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New employee probationary period