GMP Investigator
Eurofins

Job Info

---

Company 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 works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate.Eurofins believes it is a global leader in food, environmental, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and in the support of clinical studies.

In over just 30 years, Eurofins has grown from one laboratory in Nantes, France to over 50,000 staff across a network of more than 900 independent companies in over 50 countries and operating more than 800 laboratories. Eurofins offers a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products, as well as providing innovative clinical diagnostic testing services, as one of the leading global emerging players in specialised clinical diagnostics testing.

ÂIn 2020, Eurofins generatedtotal revenues of EUR â, 5.4 billion, and has been among the best performing stocks in Europe over the past 20 years.

Job Description

• Performs all GMP Operations investigations.
• Perform various root cause problem solving activities to determine root cause for investigation and to identify effective corrective and preventative action.
• Support compliance initiatives within the manufacturing and laboratory areas
• Initiate/Execute CAPAs as result of quality investigations.

Qualifications

EDUCATION and/or EXPERIENCE:

• Bachelor's Degree preferably in scientific discipline, with previous writing and/or investigation experience. Strong writing skills required.
• Minimum 2 years related experience in a pharmaceutical industry required.
• cGMP experience required. Knowledge of 21CFR Parts 210, 211, European Guidance on Advance Therapies preferred.
• Familiarity with Cell and Gene therapy modalities preferred.
• Experience with Quality document reviews and regulatory inspection processes. Working knowledge of Quality systems (ETS) and Investigation tools.

LANGUAGE SKILLS:

• Ability to read and interpret SOP's, operating and maintenance instructions and procedure manuals. Ability to speak effectively, present information and respond to questions. Ability to respond to inquiries or complaints from internal customers, regulatory agencies.

REASONING ABILITY:

• Ability to interpret and carry out instructions furnished in written, oral, diagram, mathematical or schedule form, particularly Standard Operating Procedures.
• Ability to deal with nonverbal symbolism (formulas, scientific equations, graphs, etc.).
• Ability to define problems, collect data, establish facts and draw valid conclusions.

COMPUTER ABILITY:

• Previous experience with Microsoft Office tools, including Teams and Outlook. Event Management Systems Trackwise / ETS preferred.
• Ability to utilize software to meet business needs. LIMS, SAP, MES experience preferred.

MATHEMATICAL SKILLS:

• Ability to add, subtract, multiply and divide and convert between standard and metric in all units of measurement, using whole numbers, fractions and decimals. Ability to compute rate, ratio and percent and to draw and/or interpret bar graphs.

Additional Information

Position is full-time, Monday - Friday 8:00am - 5:00pm.Candidates currently living within a commutable distance of Malvern, PA 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

What Happens Next

Our people are the backbone of what we do, so it's incredibly important we find the right individuals to join us. As a potential new recruit you'll be invited to meet the team in the form of an assessment centre or a staged interview process dependent on the role and it's requirements, this will give you the opportunity to see what working for Eurofins is really like and enable us to get you know your key skills and strengths.

Your data

As part of any recruitment process, the company collects and processes personal data relating to job applicants. The company is committed to being transparent about how it collects and uses that data and to meeting its data protection obligations.

Closing Date

We reserve the right to close or extend this position depending on application numbers. Therefore we would urge candidates to submit an application as early as possible.

Due to the high volume of applications we receive please be aware that if you do not receive a response within 4 weeks of the vacancy expiry date unfortunately, on this occasion your application has been unsuccessful.

Eurofins is aM/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.

Eurofins is aM/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.

This job has expired.