QUALITY ASSURANCE SPECIALIST
Company: Element Materials Technology
Location: Bend
Posted on: October 19, 2024
Job Description:
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.
Keywords: Element Materials Technology, Beaver Creek , QUALITY ASSURANCE SPECIALIST, Other , Bend, Oregon
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