QA Supervisor - Sterile Pharmaceutical Manufacturing

Socket.dev; San Jose (CA); On-site; USD 104,000 - 127,000; Full time

Benefits offered by this job

Health & dental

Pet insurance

401(k) plan

Life and disability insurance

Voluntary insurance options

Paid time off with annual increases

Tuition reimbursement

Internal promotion opportunities

Job summary

Wedgewood Pharmacy is seeking a hands-on QA leader to drive day-to-day quality assurance in a sterile pharmaceutical manufacturing facility. You will balance compliance with coaching and accountability while mentoring a team of QA Technicians.

You will approve materials, review investigations, manage change control, and report quality metrics. The role requires strong documentation, cross-functional collaboration, and a proactive approach to continuous improvement within a cgmp environment.

Qualifications

• 2–3 years of experience with state and federal regulations, cGMP guidelines/standards.
• Knowledge of quality systems including process/equipment validation, management review, internal audit, CAPA, and document control.
• Proven ability to lead and mentor QA team members.
• Excellent written and oral communication, organization, and presentation skills.

Responsibilities

• Lead day-to-day QA activities within a sterile pharmaceutical manufacturing facility, driving compliance and continuous improvement.
• Approve or reject starting materials, packaging, intermediates, bulk products, and finished products against specifications.
• Perform, review, and approve quality investigations with root cause analysis and corrective actions.
• Review and approve protocols and reports supporting commissioning, maintenance, and validation.
• Ensure training requirements are completed and updated.
• Create, revise, and approve controlled documents and process changes.
• Compile and report monthly quality-system metrics and identify trends.
• Participate in internal audits and risk assessments; monitor industry trends and improve processes.
• Mentor QA Technicians and drive a positive, accountable work environment.
• Collaborate with Quality Control, Validation, and Production on QMS changes.
• Identify potential adverse quality issues early and drive timely resolution.

Skills

Quality leadership

Coaching

Documentation skills

Communication skills

Cross-functional collaboration

Microsoft Office

Tools

Data-entry systems

Job description

Wedgewood Pharmacy is seeking a hands-on QA leader to drive day-to-day quality assurance in a sterile pharmaceutical manufacturing facility. You will balance compliance with coaching and accountability while mentoring a team of QA Technicians.

You will approve materials, review investigations, manage change control, and report quality metrics. The role requires strong documentation, cross-functional collaboration, and a proactive approach to continuous improvement within a cgmp environment.