Documentation Specialist

We are seeking a talented and motivated Documentation Specialist to process and review executed batch records in Operations, ensuring accuracy in compliance with cGMP, FDA regulations, and policies. The role involves assisting in update/revisions of manufacturing Standard Operating Procedures and tracking document approvals through the VEEVA document system.

What You Will Do

The Documentation Specialist will be responsible for accurately reviewing and approving executed production batch records and associated batch-related documents, arranging documents in a batch record, revising/updating Standard Operating Procedures, and maintaining acceptable cGMP and Safety training levels.

Why It Might Be a Fit

The ideal candidate will have strong documentation skills, attention to detail, and good communication skills, with the ability to work in a team environment and cope with stress associated with changes in the daily production schedule.

Requirements

• High School diploma or equivalent
• One or more years' experience in healthcare/pharmaceutical product manufacturing or quality assurance
• Strong background in pharmaceutical documentation and knowledge of cGMPs/FDA regulations
• Ability to write, revise, and review SOPs
• Strong interpersonal skills and great attention to detail
• Proficient in Microsoft Office applications (Word and Excel)
• Good communication skills both verbal and written
• Good time management skills and the ability to multitask and work independently
• Strong ability to cope with the stress associated with changes in the daily production schedule
• Familiarity with cGMPs and CFR
• Good organizational skills and ability to multi-task and perform work in a timely manner
• Ability to work in a team environment with good communication skills and ability to communicate effectively with peers, department management, and production personnel
• Basic knowledge of computer systems at a proficient level to navigate input and/or reference computerized data
• Ability to read and understand documents such as production batch records, safety rules, corporate guidelines, and standard operating procedures

Benefits

• Annual performance bonus, commission, and share potential
• Auto enrollment in a Hikma-sponsored 401(k) program at a pre-tax contribution rate of 3% of eligible pay. Hikma will match 100% of the first 6% of eligible pay that you contribute
• A generous paid time off (PTO) bank starting with 20 days (prorated based on hire date). Additional days granted upon reaching work milestone anniversaries
• 3 personal days (prorated based on hire date)
• 11 company paid holidays
• Comprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefits
• Employee discount program
• Wellbeing rewards program
• Safety and Quality is a top organizational priority
• Career advancement and growth opportunities
• Tuition reimbursement
• Paid maternity and parental leave