Quality Assurance Specialist

Eurofins • NJ

227d • $60,000 - $78,000

About The Position

Under minimal supervision, the Quality Assurance Specialist III 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.

Requirements

• A bachelor’s degree or higher in a scientific field (chemistry, biology, or life science).
• 3-5 years of experience in Quality Assurance within a laboratory or regulated industry (e.g., pharmaceuticals, biotechnology, medical devices).
• Must have experience working in a GMP facility.
• ISO 17025:2017 accredited lab experience preferred.
• Moderate understanding of microbiology and/or chemistry-related terms and testing.
• Moderate understanding of USP/EP/JP standards and guidelines.
• Moderate understanding of laboratory regulations (FDA, ISO, GLP, GMP).
• Experience with testing of pharmaceutical, cosmetic, and/or medical device products.

Nice To Haves

• 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 focused; displays good communication skills; good implementation and follow-up skills.
• Hands-on experience and strong understanding of industry regulations and how to apply them including 21 CFR Part 11, 21 CFR Part 820, ISO 17025, USP, and GxP.
• Hands-on experience with CAPA, change control, quality events, and validation documentation (IQ/OQ/PQ).
• Strong problem-solving skills include root cause analysis using formal RCA tools such as Ishikawa and 5Ys.

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.
• Maintain the internal auditing program to ensure the established techniques are followed and understood.
• Participate in the planning, preparation, and hosting of customer and regulatory audits; respond to audit reports and implement resolution of audit findings.
• Maintain the Management Review process.
• Maintain 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.
• Maintain the list of approved suppliers and subcontractors.
• 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 all quality inquiries on analytical reports and related documentation.
• Audit methods, work instructions, deviations, investigations, corrective actions, preventative actions, risk assessments, and instrument qualification/calibration paperwork.
• 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.
• Exist as a backup for all other Quality Assurance personnel.

Benefits

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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Bachelor's degree