Senior QA Specialist: GMP Oversight & Investigations

Bora Pharmaceuticals Inc; Maple Grove (MN); On-site; USD 88,000 - 125,000; Full time

Benefits offered by this job

Competitive salary

Health coverage

401(k) with employer matching

Paid time off

Professional development

Wellness programs

Employee assistance program

Job summary

Bora Bora Pharmaceuticals is seeking a Senior Product Quality Specialist to provide independent quality oversight of manufacturing and to drive quality systems in a fast-paced environment.

The role covers review of high-risk GMP documents, investigations, CAPAs, and audits, with a focus on cGMP compliance and client relationships. Strong communication and cross-functional collaboration are essential.

Qualifications

• Bachelor’s degree in a pharmaceutical/biotech ops or GMP-related field.
• Strong knowledge of cGMP regulations and quality systems.
• Excellent writing, analytical, and decision-making abilities.
• Able to manage multiple priorities in a fast-paced manufacturing environment.

Responsibilities

• Review and approve complex GMP documents and reports.
• Lead investigations, CAPAs, deviations, and quality events.
• Support audits and APRs; provide risk-based quality leadership.
• Serve as QA liaison on cross-functional teams and with clients.

Education

Bachelor's degree

Tools

SAP

Veeva

Microsoft Office

Job description

Bora Bora Pharmaceuticals is seeking a Senior Product Quality Specialist to provide independent quality oversight of manufacturing and to drive quality systems in a fast-paced environment.

The role covers review of high-risk GMP documents, investigations, CAPAs, and audits, with a focus on cGMP compliance and client relationships. Strong communication and cross-functional collaboration are essential.