QA Specialist II

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 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 Organization 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 Organizations. It also has a rapidly developing presence in highly specialized 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 decentralized 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.

Job Description

Under minimal supervision, the Quality Assurance Specialist II will ensure systems and processes are in a state of compliance with regard to internal, regulatory, and industry standards. He/she will promote a culture of quality for the Company. Candidates in this position will routinely report on the performance of the Quality System to senior leadership. Additionally, candidates will 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.

Essential Duties/Responsibilities:

• Participate in all aspects of Quality Assurance to ensure regulatory activities are performed in compliance with both internal procedures and external cGXP/ISO requirements.
• Audit 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 quality inquiries on analytical reports and related documentation.
• Maintain site-specific procedures including the Quality Manual, Standard Operating Procedures, and other site-specific Quality Assurance documents.
• Create, revise, review, and approve newly written documents and document revisions.
• Work with Operations Management to maintain the training program and ensure that laboratory personnel performing tests have completed all necessary training requirements.
• Train laboratory personnel in GXP/ISO procedures, practices, and guidelines.
• Participate in the internal auditing program to ensure the established techniques are followed and understood.
• Audit methods, work instructions, deviations, investigations, corrective actions, preventative actions, risk assessments, and instrument qualification/calibration paperwork.
• Participate in the planning, preparation, and hosting of customer and regulatory audits; respond to audit reports and implement resolution of audit findings.
• Assist senior leadership in preparing for the Management Review process.
• Assist senior leadership in maintaining the laboratory proficiency testing program.
• Collect, track, and analyze quality metrics (OOS, deviations, complaints, etc.) and train
  laboratory personnel, as needed to help reduce quality events.
• Monitor laboratory compliance with respect to lab cleanliness, training records, and other ISO/GMP-related items, as needed to help minimize laboratory errors and audit findings.
• Support quality event investigations to completion using formal root cause analysis tools.
• Support periodic summaries of audit outcomes and risk statements that identify whether there are uncontrolled risks within the QMS.
• Assist senior leadership in maintaining the list of approved suppliers and subcontractors.
• Exist as a backup for all other Quality Assurance personnel.

Qualifications

Capabilities:

• Must be a detail-oriented, self-initiating individual with strong interpersonal written and oral communication skills.
• Strong organizational skills, and ability to multitask in a dynamic, fast-paced
  environment.
• Displays sound judgment and ambition; is quality fo