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Manufacturing Compliance Specialist

1 month ago

Woodinville, United States Theery Full time

Summary:

The Manufacturing Compliance Specialist is responsible for manufacturing quality deliverables such as deviation investigations, trend assessments, CAPA, batch record review, and change controls. Additionally, the Manufacturing Compliance Specialist serves as a mentor to members of the operations team, providing training and guidance for compliance related activities.


Duties And Responsibilities:

• Primary driver of Manufacturing investigations for related non-conformances.

• Primary driver for Manufacturing change control requests

• Primary Driver for GMP audit responses / CAPA development.

• Reviewing of Manufacturing batch records and logbooks

• Championing the Inventprise quality philosophy.

• Tracking and reporting KPIs; and driving continuous improvement efforts.

• Identifying and mitigating risks in manufacturing operations that could negatively impact delivery of safe and effective products.

• Assistance with inspection readiness efforts and providing Inspection support as required.

• Build partnerships with cross functional department teams.

• Provide critical communications upward, downward, and across as deemed fit; manage compliance related decisions– acquire feedback, input, and consult as required.

• Review and approve documents, including standard operating procedures, batch records, material specifications, and validation protocols / reports.

• Ensure deviations, CAPA, change controls, and other business drivers are supported and completed in a timely fashion.

• Driving right first time (RFT) culture within Manufacturing.


Education:

Bachelor’s degree in related field is preferred. Minimum of associate’s degree and/or equivalent combination of education and experience is required.


Experience:

• 2+ years of experience in a GMP Quality or Manufacturing setting.

• Extensive knowledge of SOPs and cGMPs and the know–how to work and manage within a regulated environment.

• Experience working in a QMS

• Adaptable to a fast paced, complex, and ever-changing business environment.


Working Conditions:

• Typing and computer use for extended periods

• Must be able to sit/ stand for extended periods of time.

• Minimal work in areas that may have strong magnets.

• Must be able to occasionally work in a cleanroom environment that requires gowning.

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