Eurofins PSS Insourcing Solutions
Pharmaceutical Manufacturing QA Associate
Eurofins PSS Insourcing Solutions, Sanford, North Carolina, United States, 27330
Pharmaceutical Manufacturing QA Associate
Eurofins Scientific is an international life sciences company providing a unique range of analytical testing services across multiple industries to make life and our environment safer, healthier and more sustainable.
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
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 Bachelor's or Master's degree in a relevant discipline (e.g., microbiology, chemistry, biological sciences, bioengineering, etc.).
Bachelor's degree + 2-4 years of relevant experience
Master's 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.
Authorization to work in the United States indefinitely without restrictions or sponsorship.
Additional Information Position is full-time, Monday - Friday 8:00am - 5:00pm.
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.
Seniority level Mid-Senior level
Employment type Full-time
Job function Production
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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
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 Bachelor's or Master's degree in a relevant discipline (e.g., microbiology, chemistry, biological sciences, bioengineering, etc.).
Bachelor's degree + 2-4 years of relevant experience
Master's 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.
Authorization to work in the United States indefinitely without restrictions or sponsorship.
Additional Information Position is full-time, Monday - Friday 8:00am - 5:00pm.
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.
Seniority level Mid-Senior level
Employment type Full-time
Job function Production
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