Qualifications

• 2-3 years of experience in cGMP and related regulations, preferably in pharmaceutical or commercial compounding environments.
• Strong understanding of quality systems, including CAPA and document control.
• Demonstrated ability to lead and mentor a QA team effectively.
• Excellent written and verbal communication skills, with a focus on documentation and presentation.
• Proficiency in Microsoft Office and data-entry systems for compiling quality metrics.

Responsibilities

• Lead day-to-day Quality Assurance activities in a sterile manufacturing facility.
• Approve or reject raw materials, intermediates, and finished products according to specifications.
• Conduct and oversee quality investigations with a focus on root cause analysis and corrective action.
• Review and approve protocols for commissioning, maintenance, and validation of processes.
• Ensure training requirements are met and adapted to team needs.
• Compile and report on quality system metrics to identify trends and drive improvements.
• Mentor a team of QA Technicians while promoting a positive and accountable work environment.

Benefits

• Comprehensive health, dental, and flexible spending accounts, including pet insurance.
• Generous 401(k) retirement plan with company contributions.
• Company-paid life and disability insurance.
• Access to voluntary insurance options.
• Increasing paid time off each year.
• Tuition reimbursement for further education and growth.
• Clear opportunities for career advancement through internal job postings.