Senior Quality Specialist: Lab Compliance Chemistry

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.

About the role

Applies GMP/GLP in all areas of responsibility, as appropriate. Monitors laboratory compliance with respect to expired reagents, reagent labeling, lab cleanliness, training records, PPE adherence, and other cGXP items to help minimize laboratory audit findings.

• Perform and support internal audits, as well as help implement the resolution of internal/external audit findings.
• Review instrument qualifications to ensure work is performed as per procedure.
• Review and verify invalid data and system suitability failures.
• Review and close exceptions under Non-Routine Events, System Suitability Failure, and Deviations.
• Approve Analytical Method/Protocol/SMIS/Client Parameter per QA procedure.
• Track and analyze quality metrics (exception rate, rejection rate, etc.) and train laboratory personnel to help reduce or eliminate rework.
• Support other QA compliance-related activities as needed.
• Diagnose problems, solve simple problems, and suggest solutions to complex problems.
• Keep oneself and peers abreast of current developments and trends by reading internal procedures, attending training sessions, writing/revising SOPs, and assisting in training new employees.
• Exercise discretion and independent judgment with respect to matters of significance directly related to the management or general business operations through the data review process.
• May serve as technical advisor for analysts regarding QA/QC of data.
• Communicate with internal clients to discuss findings and notify them of any necessary rework or compliance/regulatory concerns.

Requirements

• Bachelor's degree in Chemistry or related science field.
• Minimum of three years of pharmaceutical laboratory experience with knowledge of regulatory requirements.
• Authorization to work in the United States indefinitely without restriction or sponsorship.

Preferred Qualifications

• Experience in performing pharmaceutical analytical testing.
• Computer skills including word processing, spreadsheets, PowerPoint, and database.
• Experience with cGMP and/or FDA regulated environments.
• Technical writing and review.
• Tracking action items and driving to completion.
• Ability to identify trends in recurring events.
• Batch record review, pharmaceutical testing, and room clearance activities.
• Work with the laboratory and support groups to improve quality metrics and enable CAPA implementation.
• Internal audits support.
• Review and write QAU procedures.

Schedule

Position is full-time, Monday-Friday, 8:00 a.m.-5:00 p.m. with additional hours as needed.

Benefits

• Comprehensive medical coverage.
• Life and disability insurance.
• 401(k) with company match.
• Paid holidays and vacation.
• Dental and vision options.