Pharmaceutical Manufacturing QA Associate
Pharmaceutical Manufacturing QA Associate
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Job Description
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 Monday-Friday generally 8 a.m. - 5 p.m. but may vary to meet the assay needs; overtime as needed. Candidates currently living within a commutable distance of 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
Employment Type
Full-time
