QA Team Lead

About Us

Welcome to ANI Pharmaceuticals, where we are dedicated to improving and enhancing patients' lives through the manufacturing and distribution of high-quality pharmaceutical products. With a diverse portfolio of generic and branded pharmaceuticals, ANI is a trusted partner for healthcare providers, pharmacists, and patients alike.

At ANI Pharmaceuticals, there are opportunities to contribute to our purpose every day. We value authenticity, knowledge, and hard work, and we strive to celebrate our employees in a positive environment. Our culture empowers everyone to be successful and apply their full potential.

About the Role 

This position is responsible for supporting Manufacturing and Packaging Operations to ensure compliance with applicable procedures, GMP requirements, and regulatory standards.

In addition to individual contributor responsibilities, this role provides day-to-day leadership to QA Associates, including work planning, performance management, and oversight of team deliverables in partnership with the department head.

Responsibilities

Quality Assurance (~75%)

• Perform packaging line inspections/audits and ensure compliance with SOPs and GMP requirements
• Conduct finished product inspections and evaluate physical characteristics prior to packaging
• Perform in-process checks during packaging to ensure adherence to batch record specifications
• Review and ensure compliance of batch documentation in accordance with established procedures
• Monitor GMP areas to ensure compliance with 21 CFR guidelines and internal standards
• Perform raw material and packaging material sampling
• Collect stability samples, coordinate testing, and support stability programs
• Prepare stability protocols and assist in report compilation
• Perform annual retain sample inspections and manage reserve sample inventory
• Identify and escalate quality issues, deviations, and potential risks

Team Leadership & Supervisory Responsibilities (~25%)

• Provide day-to-day oversight and guidance to QA Associates
• Assign and prioritize work based on production schedules and departmental needs in partnership with QA leadership
• Review team output to ensure accuracy, completeness, and compliance with GMP standards
• Support hiring, onboarding, and training of QA team members
• Approve employee time off and manage scheduling/coverage
• Conduct performance management activities, including mid-year and year-end reviews
• Coach and develop team members; provide ongoing feedback and support career development
• Foster a culture of accountability, teamwork, and continuous improvement
• Partner with cross-functional teams (Manufacturing, Packaging, QC) to resolve quality issues and improve processes

Skills

• Strong verbal and written communication skills
• Leadership, coaching, and team development capabilities
• Ability to work in a fast-paced, dynamic environment
• Strong problem-solving and decision-making skills
• Excellent interpersonal and collaboration skills
• Working knowledge of GMP requirements and QA processes

Requirements

• Bachelor’s degree required
• 5+ years of experience in a GMP or Quality Assurance environment (lead or senior experience preferred)
• Demonstrated ability to coordinate multiple tasks and priorities
• Ability to read, interpret, and enforce Standard Operating Procedures
• Strong attention to detail and organizational skills
• Ability to work effectively within a team environment
• Flexibility to support shift changes as needed

ANI Pharmaceuticals offers a variety of benefits to eligible employees, including health insurance coverage, life and disability insurance, retirement savings plans, paid leave programs, paid holidays and paid time off. Many of these benefits are subsidized or fully paid for by the company.