QA Manager
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Job Location:
St. Louis, MO - USA
Monthly Salary:
Not Disclosed
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
Job Description
Under directive from senior leadership the Quality Manager will ensure quality 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 report on the performance of the Quality System to senior leadership. Additionally candidates will manage and direct quality personnel assigning and assuring their daily duties are carried out in accordance with internal procedures. This position will be centrally located in the United States and will oversee quality personnel and systems at multiple locations.
Responsibilities
- Oversee in all aspects of Quality Assurance to ensure calibration activities are performed in compliance with both internal procedures and ISO/IEC 17025:2017 requirements.
- Oversee the internal auditing program nationally to ensure the established techniques are followed and understood.
- Oversee in the planning preparation and hosting of customer audits and accreditation assessments; respond to audit reports and implement resolution of audit findings; complete Supplier assessment evaluations.
- Maintain and control global procedures including Standard Operating Procedures Protocols Forms CAPAs Deviations Nonconformances Complaints/Inquiries Change Orders calibration records training records and logs.
- Manage and control the Document System nationally
- Create revise review and approve newly written documents and document revisions.
- Work with senior leadership to maintain the training program and ensure that operations personnel have completed all necessary training requirements.
- Conduct personnel training where deemed appropriate
- Overall responsibility for the Management Review process across the organization.
- Assist senior management in ensuring all licenses remain current (e.g. ISO City etc.)
- Collect track and analyze quality metrics (OOS NCMRs CAPAs complaints etc.) and train calibration 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.
- Maintain client confidentiality specifically if information about the customer is obtained from sources other than the customer (e.g. complainant assessors etc.).
- Acts impartially within the management system and communicates identified impartiality risks/concerns to management for assessment.
- Communicate any problems that might affect job performance to direct supervisor.
- Utilize lean and risk management methodologies to design implement and continuously refine standardized processes driving departmental efficiency and consistent quality.
- Exist as a backup for all other Quality Assurance personnel.
- Other duties as assigned by departmental management.
Qualifications :
Requirements
- Bachelors degree in chemistry biological science or other related science field
- 3 years of experience working in a Quality Assurance role at an ISO 17025:2017 accredited facility with a preference of at least 2 of those years being in a leadership role
- Must be a detail-oriented problem solving 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 with CAPA change control and validation documentation (IQ/OQ/PQ) is preferred.
Additional Information :
Working schedule will be Full-Time First Shift M-F 9am-5pm. Candidates currently living within a commutable distance of St. Louis MO are encouraged to apply. 25% travel may be required. No relocation assistance will be given. This position is NOT remote.
What we Offer:
- 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
Eurofins USA BioPharma Services is a Disabled and Veteran Equal Employment Opportunity employer.
Remote Work :
No
Employment Type :
Full-time
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
About Company
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 the environment safer, healthier and more sustainable. From the food you eat to the medicines you rely on, Eur ... View more
