Quality Assurance Manager
Quality Assurance Manager
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
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:
- Bachelors degree (B.S/B.A.) or higher in microbiology chemistry or related fields.
Experience:
- 5 years of relevant laboratory quality assurance experience
- 2 years of experience in a quality management position overseeing quality assurance and quality control activities.
- Must have experience working in a GMP facility.
- Must have experience working in an ISO 17025:2017 accredited facility.
- Indepth knowledge of audits to include FDA ISO internal and customer audits.
- Experience with testing of pharmaceutical cosmetic and/or medical device products.
Competencies:
- Adaptable technical and attentive to detail. Works well in a team and has the desire to grow their team.
- Capable of maintaining objectivity without undue influence.
- Displays sound judgment and ambition; is qualityfocused; displays good communication skills; good implementation and followup skills.
- Is comfortable with the goals values and philosophy of Infinity Laboratories.
Must be a detailoriented problemsolving selfinitiating individual with strong interpersonal written and oral communication skills.
Additional Information :
Position is fulltime working (Monday Friday 8:00 AM5:00 PM) overtime as needed. Candidates currently living within commutable distance to Crown Point IN are encouraged to apply.
Excellent fulltime 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 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 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.
Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
