Quality Assurance Associate - Pharmaceutical

Quality Assurance Associate - Pharmaceutical

Department:
Quality Assurance

Location:

Brighton, Michigan

Reports to:

Quality Assurance Manager

The Quality Assurance Associate is a member of the Quality Assurance department responsible for overseeing and assisting in all aspects of Quality Systems Management. The role functions in two capacities: documenting and training for CGMP quality systems, and providing QA oversight during manufacturing operations.

• Develop, review, approve, and/or maintain documents that support both Quality Assurance and Operations, including Batch Records, Protocols, Reports, Risk Assessments, Process Flow Diagrams, SOPs, Investigations, and other technical documents.
• Lead/represent QA on project teams in support of new product and manufacturing activities.
• Review and approve incoming materials, including active pharmaceutical ingredients, excipients, components, and packaging materials.
• Perform quality oversight during manufacturing operations, identifying and implementing process improvements through change control, investigations of non-conforming material, equipment, and processes, and review of manufacturing documentation.
• Perform review and approval of executed documents.
• Assist in the identification, action, and resolution of changes and issues during manufacturing activities.
• Develop and implement SOPs related to CGMP quality systems, operations, and the facility, including training and training file maintenance.
• Assist in management of quality systems company-wide, including document control, vendor quality, training, CAPA, change management, auditing, validation/qualification programs, and non-conformance investigations.
• Other duties as defined by Biovire.

• Strong work ethic and ability to accomplish tasks without supervision.
• Demonstrate leadership by words and action to foster Biovire One Team culture.
• Strong organizational skills and ability to focus on multiple projects in a fast-paced environment.
• Excellent interpersonal skills and effective communication.
• Basic computer skills (proficient in Microsoft Office applications).
• Excellent written and verbal communication skills.
• Commitment to honesty, integrity, and highest legal and ethical standards.
• Treat every person with courtesy and respect.
• Knowledge of CGMP and regulatory principles.
• Commitment to quality in the manufacturing process.
• Ability to independently analyze and resolve complex issues.
• Strong sense of initiative, accountability, and responsibility.

• BS in a scientific discipline.
• 3+ years experience in the biotech/pharmaceutical industry preferred.
• Demonstrated knowledge and understanding of CGMP and CGMP Quality Systems.