Job Description

Job Summary:

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.

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.

• 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.

• 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.

• 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.

• Trains laboratory personnel in GXP/ISO procedures, practices, and guidelines.

• Exist as a backup for all other Quality Assurance personnel.

Qualifications

Education:

• A bachelor’s degree or higher in a scientific field (chemistry, biology, or life science).

Experience:

• 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.

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 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.

Additional Information

Positions are full-time, working (Monday-Friday 8:00am-5:00pm), overtime as needed. Candidates currently **living within commutable distance to North Brunswick Township, NJ **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 a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.

Eurofins USA BioPharma Services is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.