Manufacturing QA Associate (2nd Shift)

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 Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate.

The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. It is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organisations. It also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products.

In over 30 years, Eurofins has grown from one laboratory in Nantes, France to 58,000 staff across a decentralised and entrepreneurial network of 900 laboratories in over 54 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products.

In 2021, Eurofins generated total revenues of EUR 6.72 billion, and has been among the best performing stocks in Europe over the past 20 years.

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate.

The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. It is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organisations. It also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products.

In over 30 years, Eurofins has grown from one laboratory in Nantes, France to 58,000 staff across a decentralised and entrepreneurial network of 900 laboratories in over 54 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products.

In 2021, Eurofins generated total revenues of EUR 6.72 billion, and has been among the best performing stocks in Europe over the past 20 years.

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.