Manager, QA Operations
On-site · Jupiter, Florida, United States
Job Summary
Manage day-to-day QA Operations, including implementing training and performance management for direct reports; implement and evaluate documentation and policies to maintain ISO 13485:2016 quality management system compliance; collaborate with management to identify and address documentation gaps, CAPAs, NCs, and audit findings; author and maintain quality documentation and oversee reviews of work instructions for production and quality control; support quality control with customer complaints and OOS investigations; participate in core teams delivering QA input across production through shipment; implement and track metrics for quality management; identify efficiency improvements for continuous improvement; collect and analyze quality data to facilitate proactive solutions; manage Internal Audit Program; require Bachelor’s in Life Science/related discipline and 3-5 years of managerial experience in biotech with GMP experience; strong communication, leadership, problem-solving, and team-building skills; #LI-Onsite.
Required Qualifications
- Bachelor’s Degree in Life Science, Biology, Chemistry or Pharmaceutical or related discipline
- 3-5 years of managerial experience in non-academic biotechnology related industry
- 1-3 years of supervisory experience
- Proven experience with: ISO 13485 certification, federal regulations 21 CFR 820 and 21 CFR Part 11
- Industry experience in a Good Manufacturing Practice (GMP) environment is preferred
- Thorough knowledge of analytical testing industry standards and quality assurance methodologies
- Excellent communication and presentation skills are required
- Demonstrated scientific “problem solving” skills, translated into consultative selling process where the “win” is for both the client and the company
- Ability to participate with others as a member of the team to ensure that demanding and difficult projects are handled smoothly and cooperatively to enhance success of project and maintain strong relationships within all parts of company
- Proven ability to thrive in a start-up/change oriented environment
- Great attention to detail and results driven approach
- Self-starter with ability to organize and prioritize a diverse set of responsibilities to ensure that focus on growth and success of company is achieved
- Proven coaching, mentoring, team building and leadership skills
- LI-Onsite
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