GMP QA Associate - Real-Time Batch Oversight

Eurofins PSS Insourcing Solutions; Sanford (NC); On-site; USD 52,000 - 78,000; Full time

Benefits offered by this job

Medical, dental and vision

Life and disability insurance

401(k) with company match

Paid vacation and holidays

Job summary

Eurofins USA PSS Insourcing Solutions in Sanford, NC seeks a Manufacturing QA Associate to provide on-the-floor quality assurance for drug substance manufacturing, applying GMP principles and documentation oversight.

You will review batch records in real time, support deviations and investigations, and work with cross-functional teams to meet timelines; the role includes housekeeping walkthroughs and ensuring compliance with ICH Q7 and 21 CFR 211.

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

Responsibilities

• Use fundamental knowledge of GMP and established procedures to provide quality oversight of manufacturing documentation, housekeeping, and GMP compliance.
• Ensure the site maintains compliance by contributing to quality oversight activities across functions.
• Execute real-time review of batch documentation and other manufacturing records for errors and corrections.
• Support Transfer Master Cell Banks to Manufacturing.
• Perform housekeeping and GMP walkthroughs of the facility.
• Initiate deviations in real-time and assist in investigations.
• Work in cross-functional teams to meet timelines.
• Make quality decisions in real-time per ICH Q7 and 21 CFR 211.

Skills

GMP knowledge

QA on floor

Documentation review

Cross-functional teamwork

Deviations & investigations

Education

Bachelor's degree in a related field

Master's degree (optional)

Job description

Eurofins USA PSS Insourcing Solutions in Sanford, NC seeks a Manufacturing QA Associate to provide on-the-floor quality assurance for drug substance manufacturing, applying GMP principles and documentation oversight.

You will review batch records in real time, support deviations and investigations, and work with cross-functional teams to meet timelines; the role includes housekeeping walkthroughs and ensuring compliance with ICH Q7 and 21 CFR 211.