Quality Assurance Specialist III
4 weeks ago
Element Materials Technology is seeking a highly skilled Quality Assurance Specialist III to join our team in Bend, OR.
The Quality Assurance Specialist III will assist QA Management in administering the company's quality system, ensuring compliance with regulatory standards and industry best practices. This role will involve quality systems management, document control, data management, protocol and report review, and participation in quality improvement projects.
The ideal candidate will have a strong track record of executing GxP Quality processes and advanced knowledge of GxP requirements related to pharmaceutical, medical device, and antimicrobial testing services. They will be innovative and provide solutions that reduce the cost of poor quality and compliance risks.
Key Responsibilities:- Assist site management in overseeing the company's Quality System, including investigations, deviations, CAPAs, internal/external audits, training programs, equipment qualification/calibration/maintenance, document control, inspection and testing methods, and compliance with 21 CFR Parts 11, 210, 211, and ISO 17025.
- Participate in the review and approval of investigations, CAPAs, out-of-specification events, deviations, and special assessments to ensure compliance with current regulatory standards.
- Participate in and support operational excellence activities, such as SQDC, Gemba walks, and Kaizens.
- Participate or oversee the approval of routine testing, special projects, validation projects, or other specialized studies to ensure successful completion in a timely and effective manner.
- Support QA Management in responding to customer requests for information pertaining to regulatory and compliance issues in a timely and accurate manner.
- Play a key lead role in departmental and/or company-wide projects designed to improve customer service.
- Provide QA review and approval of E&L study protocols, reports, and associated T-SPCs.
- Support QA Management in hosting and performing customer audits and in the planning of customer audit corrective actions and responses.
- Assist QA Management in fielding questions and resolving issues that arise internally within the Quality Assurance team.
- Assist QA Management in coordinating the training program and providing training within the QA team.
- Play a lead role in becoming a key department source on compliance regulations both to laboratory personnel and internally within the QA team.
- Foster a healthy relationship between QA and Operations to ensure customer and regulatory expectations are met consistently.
- Assist the QA Management in hosting and responding to regulatory inspections.
- Provide document ownership in key Quality System areas, including the biennial review and ongoing maintenance of procedures to support continual improvement activities.
- 5 to 10 years' experience with a strong track record of executing GxP Quality processes.
- Bachelor's degree (or equivalent qualifications and experience) in a relevant scientific or engineering discipline.
- Advanced knowledge of GxP requirements related to pharmaceutical, medical device, and/or antimicrobial testing services.
- Be innovative and provide solutions that reduce the cost of poor quality and compliance risks.
- Be proactive in monitoring changing regulatory expectations and disseminating them effectively throughout the organization.
- Communicate effectively with site management to promote a Quality culture and emphasize the importance of compliance and quality objectives.
- Think broadly across systems to assist management in designing processes to support quality principles and reduce error.
- Be able to identify and mitigate risks accordingly.
- Participate in site meetings to drive harmonization projects, promote development and implementation of company-wide projects such as eQMS and LIMS, and collaborate effectively with fellow Quality colleagues.
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