Quality Assurance Manager--Eurofins - Eurofins PSS Insourcing Solutions, LLC

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 is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. Eurofins 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. The Group also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products.

In over just 30 years, Eurofins has grown from one laboratory in Nantes, France to 55,000 staff across a decentralised and entrepreneurial network of 900 laboratories in over 50 countries. 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.

Candidates in this position are responsible for leading a QA team, implementing the Quality System, and maintaining Quality Records. Incumbents will help identify CAPAs, Deviations, Investigations, Change Controls, Process Improvements, and Root Cause Analysis. Candidates will participate in both internal (annual, in-process, for cause, etc.) and external (client, regulatory agencies, accreditation bodies, etc.) audits. The Quality Manager will routinely report on the performance of the Quality System to senior leadership while maintaining and actively working towards improving the Quality System.

Essential Duties/Responsibilities

• Manages the Quality Department.
• Oversees all aspects of Quality Assurance to ensure regulatory activities are performed in compliance with both internal procedures and external cGXP/ISO requirements.
• Oversees the internal auditing program to ensure the established techniques are followed and understood; maintains and controls the audit records.
• Responsible for the planning and preparation of customer and regulatory audits.
• Serves as site interface to the Food and Drug Administration (FDA) and other groups conducting audits of the facility.
• Oversees the Management Review process.
• Reports on the performance of the Quality System to senior leadership during the Management Review process.
• Oversees the laboratory proficiency testing program.
• Maintains the list of approved suppliers and subcontractors.
• Maintains accurate and current documentation of the Quality Manual, Quality Procedures, Laboratory Operating Procedures, records, and other documents.
• Creates, revises, reviews, and approves newly written documents and document revisions.
• Identifies and records any problems relating to Quality and the Quality System and initiates corrective action to prevent the recurrence of similar problems.
• Addresses and controls any deviations and/or nonconformities from current procedures and techniques, determines and oversees corrective and preventive measures.
• Conveys, upholds, and reinforces the quality policy and objectives of the laboratory to employees and customers.
• Audits methods, work instructions, deviations, investigations, corrective actions, preventative actions, risk assessments, and instrument qualification/calibration paperwork.
• Audits various reports prior to issuance (e.g. analysis reports, method validation reports, research and development reports (as needed), special project reports, etc.).
• Serve as site contact for all quality inquiries on analytical reports and related documentation.
• Works with Operations Management to maintain the training program and ensure that laboratory personnel performing tests have completed all necessary training requirements.
• Trains laboratory personnel in GXP/ISO procedures, practices, and guidelines.
• Maintains documentation in accordance with the Quality System, including overseeing the SOP program, document control, and change control.
• Reviews Quality Agreements and works with senior leadership to maintain compliance with the documents.
• Assist senior management in ensuring the company’s registrations and accreditations remain current (e.g. FDA, ISO, GDUFA, etc.).

Exist as a backup for all other Quality Assurance personnel

Education:

• Bachelor’s degree (B.S/B.A.) or higher in microbiology, chemistry, or related fields.

Experience:

• 5 years of relevant laboratory quality assurance experience
• 2 years of experience in a quality management position overseeing quality assurance and quality control activities.
• Must have experience working in a GMP facility.
• Must have experience working in an ISO 17025:2017 accredited facility.
• In-depth knowledge of audits to include FDA, ISO, internal, and customer audits.
• Experience with testing of pharmaceutical, cosmetic, and/or medical device products.

Competencies:

• Adaptable, technical, and attentive to detail. Works well in a team and has the desire to grow their team.
• Capable of maintaining objectivity without undue influence.
• Displays sound judgment and ambition; is quality-focused; displays good communication skills; good implementation and follow-up skills.
• Is comfortable with the goals, values, and philosophy of Infinity Laboratories.

Must be a detail-oriented, problem-solving, self-initiating individual with strong interpersonal written and oral communication skills.

Position is full-time, working (Monday - Friday 8:00 AM-5:00 PM), overtime as needed.  Candidates currently living within commutable distance to Crown Point, IN 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 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 a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.