Quality Assurance Manager

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 inprocess 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 companys registrations and accreditations remain current (e.g. FDA ISO GDUFA etc.).

Exist as a backup for all other Quality Assurance personnel

Qualifications : Education :

Experience :

Competencies :

Must be a detailoriented problemsolving selfinitiating individual with strong interpersonal written and oral communication skills.

Additional Information :

Positions are fulltime working MondayFriday 8am5pm overtime as needed.  Candidates currently  living within commutable distance to San Diego CA  are encouraged to apply.

Excellent full time benefits including comprehensive medical coverage dental and vision options

Compensation : $80000$110000 per year

What Happens Next

Our people are the backbone of what we do so its incredibly important we find the right individuals to join us. As a potential new recruit youll be invited to meet the team in the form of an assessment centre or a staged interview process dependent on the role and its 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.

Remote Work : Employment Type :

Fulltime

Key Skills

Quality Assurance,FDA Regulations,Food Industry,Food Safety Experience,ISO 9001,Quality Systems,Food Processing,Quality Control,Quality Management,QA / QC,Selenium,HACCP

Vacancy : 1

Salary : $80,000 - $110,000