Manufacturing Quality Assurance - CAPA Specialist

Fairview Health Services • Minneapolis, MN • 5h ago

Job Overview

Location : FV Offices at Kasota, Minneapolis MN

Hours : 80 hours bi-weekly

Schedule : day

This position is a quality assurance compliance role which supports the Fairview 503B manufacturing pharmacy, IntegraDose, in its operations and production by ensuring that the non-conformance and corrective and preventative action (CAPA) quality systems are compliant with the cGMP standards promulgated under Sections 503B of the US Food, Drug & Cosmetic Act.

This role requires a high level of writing proficiency and is considered a writing-intensive position. The successful candidate will be responsible for producing complex, high-volume written content that demands accuracy, clarity, and adherence to regulatory standards. Candidates must be capable of drafting, editing, and reviewing a substantial volume of documents with precision and consistency under tight deadlines.

Primary Responsibilities :

Collaborate with the Manufacturing Quality Assurance Program Manager to maintain the IntegraDose non-conformance and CAPA systems. This job will assume ownership and accountability for event investigations and CAPA management, including:

Perform and/or coordinate non-conformance investigations working closely with subject matter experts (SMEs) in operations, production, and quality to obtain information necessary to complete and close events. Evaluate investigation summaries by providing feedback to personnel supporting investigations.

Perform root cause analysis (RCA) utilizing tools to ensure that root cause is properly identified. Determine/Develop and implement effective CAPAs to address root cause(s).

Review and approve final investigations and CAPAs.

Manage the non-conformance event investigation system, including monitoring open events and CAPAs as well as prioritizing events/CAPA to ensure timely review and closure.

Perform CAPA effectiveness checks to ensure actions have addressed root cause(s). Perform additional RCA and develop new CA/PAs when ineffective.

Generate non-conformance and CAPA status reports for management providing recommendations for escalation as necessary.

Support the improvement and maintenance of Quality System Event and CAPA procedures, forms, CAPA software, and CAPA training programs.

Additional Responsibilities:

Partners with Production providing support for efficient and successful manufacturing of product, including:

Generation and control of production records, such as batch records, labels, and disposition records.

Performing cGMP review of completed manufacturing records and analytical testing results, including reconciliation and archiving.

Generating and maintaining documentation to support validations, stability studies, and commercial production.

Supporting environmental monitoring (EM) functions by generating event records, evaluating and trending test data, and providing notification of excursion events to production and management.

Required

Education

Bachelor's degree in Science, Microbiology, or Engineering or related field and/or 6 years of equivalent experience.

Documented training in cGMP quality system functions such as CAPA, RCA, or Environmental Monitoring

Experience

5 years of progressive experience within cGMP quality operations and FDA regulated environments, which may include:

Experience within a pharmaceutical laboratory or manufacturing environment providing familiarity with manufacturing process and operations, automation, equipment/facilities validation

Experience within a quality assurance (QA) role in an FDA regulated environment

2+ years' demonstrated RCA/CAPA experience, including investigation, review, and authoring

Strong understanding of 21 CFR Part 210/211 requirements and knowledge of tools, concepts and methodologies of quality assurance and compliance systems, e.g., FDA, MN BOP, DEA

License/Certification/Registration

None

Preferred

Education

Experience

3 - 5 years' experience within a pharmaceutical laboratory or manufacturing environment

2+ years' experience within a 503B outsourcing facility and/or aseptic/parenteral manufacturing environment in a quality role

Experience with MasterControl software desired

License/Certification/Registration

ASQ Certification in Quality Improvement Associate, or similar

Benefit Overview

Fairview offers a generous benefit package including but not limited to medical, dental, vision plans, life insurance, short-term and long-term disability insurance, PTO and Sick and Safe Time, tuition reimbursement, retirement, early access to earned wages, and more! Please follow this link for additional information: https://www.fairview.org/careers/benefits/noncontract

Compensation Disclaimer

The posted pay range is for a 40-hour workweek (1.0 FTE). The actual rate of pay offered within this range may depend on several factors, such as FTE, skills, knowledge, relevant education, experience, and market conditions. Additionally, our organization values pay equity and considers the internal equity of our team when making any offer. Hiring at the maximum of the range is not typical. If your role is eligible for a sign-on bonus, the bonus program that is approved and in place at the time of offer, is what will be honored.

EEO Statement

EEO/Vet/Disabled: All qualified applicants will receive consideration without regard to any lawfully protected status

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