Role OverviewThe QA Specialist I is responsible for providing on-the-floor support to manufacturing, filling, and packaging operations to ensure compliance with cGMP, SOPs, and applicable regulatory requirements.
What You Will Do
Perform quality checks, document inspection activities, assist in batch record review, and support deviation documentation under the guidance of senior QA staff.
Why It Might Be a Fit
The role requires a basic understanding of cGMP and regulatory requirements, proficiency in inspection methodologies, and the ability to follow procedures and work collaboratively in a team environment.
Requirements
- High School Diploma or equivalent required
- Associate degree in a scientific or technical discipline preferred
- Minimum 0–2 years of experience in Quality Assurance, Manufacturing, or a regulated industry (pharmaceutical/biotechnology preferred)
- Basic understanding of cGMP and regulatory requirements for pharmaceutical production
- Proficiency with Microsoft Office applications (Word, Excel, PowerPoint)
- Strong attention to detail, communication, and organizational skills
- Ability to follow procedures, take direction, and work collaboratively in a team environment
Benefits
- Competitive Compensation including base salary and annual performance bonus
- Paid Time Off, holidays, and parental leave
- Generous healthcare benefits, HSA match, 401k match, employer paid life and disability insurance, pet insurance, wellness discounts and much more!
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