Pharmaceutical Manufacturing QA Associate (2nd Shift)
Pharmaceutical Manufacturing QA Associate (2nd Shift)
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Job Description
POSITION SUMMARY:
The Manufacturing QA Associate contributes to Quality Assurance on the floor activities related to drug substance manufacturing. The colleague uses fundamental knowledge of GMP and established procedures methodologies to provide quality oversight of manufacturing documentation housekeeping and overall GMP compliance. The Associate ensures the site performs in a state of compliance by contributing to Quality oversight activities while fostering an empowered culture of quality across all functions.
CORE JOB DUTIES:
- Performs duties with the guidance of Sr. Associates
- Execute real time review of batch documentation and other manufacturing documentation analyzing for errors corrections and compliance
- Support Transfer Master Cell Banks to Manufacturing
- Perform housekeeping and GMP walkthroughs of facility
- Initiate deviations in real time and assists in investigations
- Work in cross functional teams to meet and exceed timelines
- Execute or review room and line clearances
- Makes quality decision in real time according to regulations ICH Q7 and 21CFR211 and internal procedures
ADDITIONAL RESPONSIBILITIES
- Support/initiate analytical test results initial investigation on the floor
- Reviews and may approve manufacturing analytical testing on the floor
- Uses analytical skills to help ensure shop floor compliance to internal standards and procedures
- Draft and review Standard Operating Procedures
- Work independently and with minimal supervision
- Provides excellent communication
- Perform other duties as assigned and take ownership to support the implementation of activities needed including but not limited to facility start-up and continuous operations.
Qualifications :
- A Bachelors or Masters degree in a relevant discipline (e.g. microbiology chemistry biological sciences bioengineering etc.).
- Bachelors degree 2-4 years of relevant experience
- Masters degree up to 2 years of relevant experience
- Relevant experience includes:
- Quality Assurance in GMP facilities drug substance preferred
- Batch record review housekeeping monitoring GMP document review and/or creation.
- Reviewing deviation reports change controls CAPA and analytical data.
- Experience with Data Integrity
- Knowledge of and experience in GMP following applicable regulations or willingness to become GMP proficient.
- Valid drivers license and personal transportation
Additional Information :
Position is Full Time Mon-Fri 3pm-11pm. Candidates currently living within a commutable distance of Sanford NC are encouraged to apply.
What we offer:
- 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
- Yearly goal-based bonus & eligibility for merit-based increases
Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.
Remote Work :
No
Employment Type :
Full-time
Employment Type
Full-time