Quality Assurance Supervisor in a Pharmaceutical Manufacturing Environment
Wedgewood · San Jose, CA · 1 wk ago
Quality Assurance$115k/yrFull-time
At Wedgewood Pharmacy, we are dedicated to improving the lives of animals through customized medication and compassionate care. Every role in our organization contributes to helping pets live healthier, happier lives. We are a team driven by purpose, quality, and a shared commitment to animal health.
Schedule
This is an onsite position, working Monday - Friday, 8:00am - 4:30pm.
Responsibilities
- 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.
- 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.
Requirements
- 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.
Qualifications
- 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.
Benefits
- A comprehensive benefits package that includes health, dental, and flexible spending accounts, and 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.
Pay
$115,000 - $115,000 USD