Quality Document Control Lead - GMP & Audit Readiness

Bryllan LLC; Brighton (MI); On-site; USD 70,000 - 95,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

Life Insurance

Paid Time Off

Job summary

Biovire is seeking a Quality Document Control Supervisor to lead the controlled documentation program for pharmaceutical drug product and medical device manufacturing at our Brighton, Michigan site. This hands-on role oversees Master Batch Records, SOPs, and archival processes in a fast-paced GMP environment.

The successful candidate will drive document control improvements, support audits, and collaborate across Quality, Manufacturing, and Process Engineering to ensure accurate, controlled

Qualifications

• Associate degree or equivalent教育/experience.
• Minimum 2 years in pharmaceutical industry or a similarly regulated environment.
• Minimum 2 years of experience with a controlled document management system.
• Knowledge of cGMP and regulatory principles including 21 CFR Parts 11, 210, 211, 820 and ICH guidance.
• Strong attention to detail and ability to correct documentation errors.
• Ability to manage multiple priorities and deadlines in a fast-paced environment.

Responsibilities

• Oversee day-to-day Quality Document Control function, team workflow and priorities.
• Support development and revisions of Master Batch Records and batch record changes.
• Control the creation, routing, and control of SOPs, forms, protocols, and documents.
• Issue controlled copies of batch records to Manufacturing and track issuance.
• Partner with Engineering and other functions to support new products.
• Maintain archival records, periodic reviews, and change controls.
• Provide document control support during audits and inspections.
• Generate QDC metrics for monthly reporting and management review.

Skills

Pharma experience

Controlled document management

cGMP knowledge

Attention to detail

Communication skills

Education

Associate degree

Tools

Adobe Acrobat

Microsoft Word

PDF workflows

Job description

Biovire is seeking a Quality Document Control Supervisor to lead the controlled documentation program for pharmaceutical drug product and medical device manufacturing at our Brighton, Michigan site. This hands-on role oversees Master Batch Records, SOPs, and archival processes in a fast-paced GMP environment.

The successful candidate will drive document control improvements, support audits, and collaborate across Quality, Manufacturing, and Process Engineering to ensure accurate, controlled