Element has a current opening for a Quality Assurance (QA) Specialist III at our growing lab in Bend, OR.
The Quality Assurance (QA) Specialist III role assists QA Management in administering the company's quality system. This is accomplished through Quality systems management, document control, data management, protocol and report review, and participation in various quality improvement projects. Overall, the QA Specialist III position presents the employee with an opportunity to both learn the skills required to advance in the management field of QA and at the same time play a crucial role in the company's long-term success.
This position presents the employee with an opportunity to contribute first-hand to the success of Element through assisting with the management and oversight of key Quality processes. This position will report to the site QA Manager.
Assist site management in overseeing the company's Quality System including, but not limited to: Investigations, Deviations, CAPAs; internal/external audits; training program; 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 to current regulatory standards.
Participate in and support OpEx 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 the response to all 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 which includes the biennial review and ongoing maintenance of the procedures to support continual improvement activities.
Requirements:
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. Having the ability to assess operational/compliance weaknesses, redundancies and inefficiencies and work with site QA Management to incorporate process improvements.
Be proactive in monitoring changing regulatory expectations and being able to disseminate them effectively throughout the organization.
Communicate effectively with the 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.