Quality Assurance Supervisor in a… at Wedgewood… · San Jose

When will you work?

This is an onsite position, working Monday - Friday, 8:00am - 4:30pm.

What you’ll do:

• Lead day-to-day Quality Assurance activities within a sterile pharmaceutical manufacturing facility, helping ensure our products consistently meet established standards for safety, identity, strength, quality, and purity. You will combine hands-on quality systems expertise with people leadership to strengthen compliance, solve problems, and drive continuous improvement across the site.
• 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.

Who you are:

• A hands-on quality leader who can balance strong compliance standards with coaching, collaboration, and accountability.
• Highly organized and detail-oriented, with excellent documentation skills and the ability to identify potential adverse quality issues.
• A confident written and verbal communicator with strong presentation skills and the ability to work effectively across departments.
• 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.

What you’ve done:

• 2-3 years of experience working with state and federal regulations, cGMP guidelines/standards, and industry best practices; experience in a commercial compounding outsourcing or pharmaceutical facility is preferred.
• 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.

What’s in it for you:

• A comprehensive benefits package that includes health, dental, and flexible spending accounts, and of course, pet insurance!
• 401(k) retirement plan with a generous company contribution to help you save for the future
• 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!