Manager, QA Operations
Maravai LifeSciences
3 hours ago
Remote friendly (Jupiter, FL)
United States
Operations
Manager, QA Operations (Quality Assurance)
Responsibilities:
- Manage day-to-day Quality Assurance operations, including training and performance management for direct reports.
- Implement and periodically evaluate documentation and policies to ensure compliance with organizational quality standards, ISO 13485:2016, and statutory/regulatory requirements.
- Collaborate with management to close documentation/process gaps; address CAPAs, NCs, and audit findings.
- Author and maintain quality documentation; oversee timely reviews of work instructions for production and quality control.
- Support Quality Control with customer complaints and Out of Specification (OOS) investigations.
- Participate on core teams; provide QA deliverables from production through testing and shipment.
- Implement and track quality management performance metrics.
- Identify and implement efficiency improvements for Continuous Improvement.
- Collect and analyze quality data to facilitate proactive solutions.
- Manage the Internal Audit Program.
- Perform other duties as required.
Qualifications/Skills:
- Bachelor’s degree in Life Science, Biology, Chemistry, Pharmaceutical, or related field.
- 3–5 years managerial experience in non-academic biotechnology; 1–3 years supervisory experience.
- Proven experience with ISO 13485 certification and regulations 21 CFR 820 and 21 CFR Part 11.
- GMP environment experience preferred.
- Thorough knowledge of analytical testing standards and QA methodologies.
- Excellent communication/presentation; strong scientific problem-solving; ability to collaborate in a fast-changing/start-up environment.
- Detail-oriented, results-driven; self-starter; proven coaching/mentoring/leadership.
Benefits:
- Medical plans with HSA/FSA options; RSU/stock purchase plan; fertility & family planning assistance; additional optional benefits (including pet insurance); retirement contributions; holidays and paid time off.
Application instructions:
- Visit the career site: https://www.maravai.com/careers/
Responsibilities:
- Manage day-to-day Quality Assurance operations, including training and performance management for direct reports.
- Implement and periodically evaluate documentation and policies to ensure compliance with organizational quality standards, ISO 13485:2016, and statutory/regulatory requirements.
- Collaborate with management to close documentation/process gaps; address CAPAs, NCs, and audit findings.
- Author and maintain quality documentation; oversee timely reviews of work instructions for production and quality control.
- Support Quality Control with customer complaints and Out of Specification (OOS) investigations.
- Participate on core teams; provide QA deliverables from production through testing and shipment.
- Implement and track quality management performance metrics.
- Identify and implement efficiency improvements for Continuous Improvement.
- Collect and analyze quality data to facilitate proactive solutions.
- Manage the Internal Audit Program.
- Perform other duties as required.
Qualifications/Skills:
- Bachelor’s degree in Life Science, Biology, Chemistry, Pharmaceutical, or related field.
- 3–5 years managerial experience in non-academic biotechnology; 1–3 years supervisory experience.
- Proven experience with ISO 13485 certification and regulations 21 CFR 820 and 21 CFR Part 11.
- GMP environment experience preferred.
- Thorough knowledge of analytical testing standards and QA methodologies.
- Excellent communication/presentation; strong scientific problem-solving; ability to collaborate in a fast-changing/start-up environment.
- Detail-oriented, results-driven; self-starter; proven coaching/mentoring/leadership.
Benefits:
- Medical plans with HSA/FSA options; RSU/stock purchase plan; fertility & family planning assistance; additional optional benefits (including pet insurance); retirement contributions; holidays and paid time off.
Application instructions:
- Visit the career site: https://www.maravai.com/careers/