Quality Assurance Manager
3315 Seaway Blvd. Everett, WA 98203 US
Position Title: Quality Assurance Manager
Position Description: Protingent has an exciting direct hire opportunity for a Quality Assurance Manager with our client in Everett, Washington.
- Lead the quality team and represent quality on the division’s management team.
- Manage and execute a quality management program consistent with pharmaceutical manufacturer requirements for API starting material.
- Execute and enhance quality aspects of project-specific plans to support company goals.
- Participate in overall company initiatives to apply quality principles to procedures and standards.
- Review design specifications, procedures, and other technical documents for quality, supporting company initiatives.
- Oversee Change Control for processes subject to Quality requirements.
- Communicate quality objectives and requirements to company management and co-workers with a goal to foster a company-wide culture of compliance.
- Develop personnel training related to quality and good manufacturing practices.
- Oversee implementation and training of a Laboratory Information Management System (LIMS).
- Oversee batch record approval process, responsible manager for quality attributes of batch.
- Lead and coordinate customer and regulatory agency audit/inspections of operations related to quality.
- Direct the resolution of findings and follow-up.
- Participate in team interactions with customers, representing quality.
- Signatory to Quality Agreements associated with Supply Agreements.
- Manage Corrective and Preventive Action (CAPA) program, Continuous Improvement initiatives, Risk Management, and Out-of-Specification Investigations.
- Manage the audit program, including regular internal audits and a supplier audit program.
- Other responsibilities to support company initiatives.
- BS or graduate degree in a quality assurance-related field or a technical discipline which includes quality requirements. (Extensive equivalent QA experience in a pharmaceutical discipline may be considered as a substitute for academic degree.)
- 7-10 years of experience in either a QA function or combination of quality assurance and radiopharmaceutical manufacturing under CGMP requirements.
- Current certification in a Pharmaceutical Quality-related discipline is a plus.
- The ideal candidate will have experience working in quality program development for manufacture of API, API starting material, or pharmaceutical ingredients.
- Must have keen attention to detail with the ability to read and interpret regulatory requirements and industry standards and apply information to quality standards.
- Must have experience with CAPA, Root Cause Analysis, Continuous Improvement, and OOS investigations.
- Strong written and oral communications skills are required.
- Understand the principles of radiation safety and apply worker safety considerations to procedures, with the guidance of the company's radiation safety experts. Training in radiation safety is provided for the successful candidate who has no experience in this technical area.
- Demonstrated success in managing a team of technical professionals and interacting with peers, collaborating toward successful completion of common goals.
- High degree of trust and integrity, communicate openly and display respect and a desire to foster teamwork.
- Military experience is a plus.
- Direct Hire
- Salary Range: Level 12: $157,405 - $218,119
- ITAR obligations are associated with this role, U.S. citizenship, U.S. legal permanent resident status, or protected person status under 8 U.S.C. § 1324b(a) (1), (3) is required.
About Protingent: Protingent is a niche provider of top Engineering and IT talent to Software, Electronics, Medical Device, Telecom, and Aerospace companies nationwide. Protingent exists to make a positive impact and contribution to the lives of others as well as our community by providing relevant, rewarding, and exciting work opportunities for our candidates.