Eurofins
Manufacturing QA Associate (2nd Shift)
On site · Sanford, NC
This role is on site in Sanford, NC.
PeopleSeek Talent does not submit applications. The button opens the employer's own page; this listing was verified 1 day ago.
PayNot listed
Work arrangementOn site
Who can applyPeople who can work in Sanford, NC
LevelEntry level
TypeFull time
Occupationmanufacturing manager
Languageen
Posted
Last verified
StatusNot seen lately
About the role
Job Description
The Manufacturing QA Associate contributes to Quality Assurance on the floor activities related to drug substance manufacturing.
- Use fundamental knowledge of GMP, and established procedures methodologies to provide quality oversight of manufacturing documentation, housekeeping, and overall GMP compliance
- Ensure the site performs in a state of compliance by contributing to Quality oversight activities while fostering an empowered culture of quality across all functions
- 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 assist in investigations
- Work in cross-functional teams to meet and exceed timelines
- Execute or review room and line clearances
- Make quality decisions in real-time according to regulations ICH Q7 and 21CFR211 and internal procedures
- Support/initiate analytical test results initial investigation on the floor
- Reviews and may approve manufacturing analytical testing on the floor
Qualifications
- Bachelor's degree and 2-4 years of relevant experience or a Master's degree and up to 2 years of relevant experience
- 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
Additional Information
This position is Full-Time, Tuesday-Saturday 3pm-12am. 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.
Qualifications
- Bachelor's degree and 2-4 years of relevant experience or a Master's degree and up to 2 years of relevant experience
- 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
Listed via Eurofins · first seen · last verified