This role is in Sanford NC.
POSITION RESPONSIBILITIES:
- Review and approve QA documentation including validation protocols method transfers and compendial assessments.
- Provide final QA approval for change controls CAPAs deviations and lab investigations (OOS/OOT/OOE)
- Support electronic record reviews and compendial change documentation.
- Make real-time quality decisions in compliance with cGMP and regulatory standards.
- Collaborate cross-functionally to resolve technical and quality issues.
- Contribute to start-up activities and performed additional QA duties as needed.
Qualifications :
- Bachelors or Masters Degree in relatable field (Microbiology Chemistry Pharmaceuticals etc.)
- Bachelors degree and 6-8 years of experience
- Masters degree and 4-6 years of experience
- Experience in a cGMP microbiology lab is required as well as familiarity with USP JP and EMEA standards.
- Strong understanding of data integrity root cause analysis and quality systems (deviations CAPAs change controls)
- Prior QA experience supporting QC documentation investigations
- Effective team player with strong communication and problem-solving skills
- Valid drivers license and personal transportation
- Authorization to work in the United States indefinitely without restriction
Additional Information :
Position is full-time Monday-Friday 8am-5pm Candidates currently living in a commutable distance to Sanford NC are encouraged to apply.
Excellent full time benefits including comprehensive medical coverage dental and vision options
Life and disability insurance
401(k) with company match
- Paid vacation and holidays
Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.
Remote Work :
No
Employment Type :
Full-time