QA Team Lead

Job TitleQuality Assurance SupervisorJob DescriptionAbout UsWelcome 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 RoleThis 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.ResponsibilitiesQuality Assurance (~75%)Perform packaging line inspections/audits and ensure compliance with SOPs and GMP requirementsConduct finished product inspections and evaluate physical characteristics prior to packagingPerform in-process checks during packaging to ensure adherence to batch record specificationsReview and ensure compliance of batch documentation in accordance with established proceduresMonitor GMP areas to ensure compliance with 21 CFR guidelines and internal standardsPerform raw material and packaging material samplingCollect stability samples, coordinate testing, and support stability programsPrepare stability protocols and assist in report compilationPerform annual retain sample inspections and manage reserve sample inventoryIdentify and escalate quality issues, deviations, and potential risksTeam Leadership & Supervisory Responsibilities (~25%)Provide day-to-day oversight and guidance to QA AssociatesAssign and prioritize work based on production schedules and departmental needs in partnership with QA leadershipReview team output to ensure accuracy, completeness, and compliance with GMP standardsSupport hiring, onboarding, and training of QA team membersApprove employee time off and manage scheduling/coverageConduct performance management activities, including mid-year and year-end reviewsCoach and develop team members; provide ongoing feedback and support career developmentFoster a culture of accountability, teamwork, and continuous improvementPartner with cross-functional teams (Manufacturing, Packaging, QC) to resolve quality issues and improve processesSkillsStrong verbal and written communication skillsLeadership, coaching, and team development capabilitiesAbility to work in a fast-paced, dynamic environmentStrong problem-solving and decision-making skillsExcellent interpersonal and collaboration skillsWorking knowledge of GMP requirements and QA processesRequirementsBachelor's degree required5+ years of experience in a GMP or Quality Assurance environment (lead or senior experience preferred)Demonstrated ability to coordinate multiple tasks and prioritiesAbility to read, interpret, and enforce Standard Operating ProceduresStrong attention to detail and organizational skillsAbility to work effectively within a team environmentFlexibility to support shift changes as neededThe base salary range for this position is $80,000-$100,000; the exact salary depends on various factors such as experience, skills, education, location, competencies and industry-specific knowledge.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.Job InfoJob Identification 1405Locations 70 Lake Drive, East Windsor, New Jersey, 08520, US (On-site)