Quality Assurance Supervisor in a Pharmaceutical Manufacturing Environment

Wedgewood Pharmacy • San Jose, CA

6d • Onsite

About The Position

Wedgewood Pharmacy is seeking a Quality Assurance Supervisor to lead day-to-day Quality Assurance activities within a sterile pharmaceutical manufacturing facility. This role is crucial in ensuring our products consistently meet established standards for safety, identity, strength, quality, and purity. The position combines hands-on quality systems expertise with people leadership to strengthen compliance, solve problems, and drive continuous improvement across the site. The ideal candidate is a hands-on quality leader who can balance strong compliance standards with coaching, collaboration, and accountability. They should be highly organized, detail-oriented, with excellent documentation skills and the ability to identify potential adverse quality issues. Strong written and verbal communication, presentation skills, and the ability to work effectively across departments are essential. Knowledge of cGMP requirements, state and federal regulations, and quality-system best practices is required. Proficiency with Microsoft Office and data-entry systems, with the ability to compile, interpret, and clearly communicate quality metrics, is also necessary.

Requirements

• 2-3 years of experience working with state and federal regulations, cGMP guidelines/standards, and industry best practices.
• Strong working knowledge of quality systems, including process/equipment validation, management review, internal audit, CAPA, and document control.
• Demonstrated knowledge of management strategies and their practical application in the workplace, with the ability to lead and mentor QA team members.
• Demonstrated written and oral communication, organization, documentation, and presentation skills.
• Knowledgeable in cGMP requirements, state and federal regulations, and quality-system best practices.
• Proficient with Microsoft Office and data-entry systems, with the ability to compile, interpret, and clearly communicate quality metrics.

Nice To Haves

• Experience in a commercial compounding outsourcing or pharmaceutical facility is preferred.

Responsibilities

• Approve or reject starting materials, packaging and labeling materials, intermediates, bulk products, and finished products against established specifications.
• Perform, review, and approve quality investigations, ensuring appropriate root cause analysis, corrective actions, and product disposition.
• Review and approve protocols and executed reports supporting commissioning, maintenance, and validation of facilities, processes, and equipment.
• Ensure initial and continuing training requirements are completed and adapted based on team and business needs.
• Create, revise, and approve controlled documents and process changes.
• Compile and report monthly quality-system metrics, identify trends, and drive continuous improvement initiatives.
• Participate in internal audits and risk assessments; monitor relevant industry trends and recommend improvements.
• Lead and mentor a team of QA Technicians, setting clear expectations and ensuring department goals and deadlines are met.
• Build a positive, accountable work environment through effective communication, coaching, performance management, and team development.
• Partner closely with Quality Control, Validation, and Production on QMS changes, improvements, and routine cGMP activities.
• Identify potential adverse quality issues early and help drive timely, compliant resolution.
• Perform other duties as assigned to support appropriate quality practices across the site.

Benefits

• health, dental, and flexible spending accounts
• pet insurance
• 401(k) retirement plan with a generous company contribution
• Company Paid Life and disability insurance
• Access to voluntary insurance options
• A generous paid time off program that increases every year
• Tuition reimbursement
• Opportunity for growth - We believe in promoting from within and do so through our internal job posting program!

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: No Education Listed