QA Team Lead

ANI Pharmaceuticals•Hightstown, NJ

4d•$80,000 - $100,000

About The Position

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.

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
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

Responsibilities

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
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