Quality Assurance Specialist

Quality Assurance SpecialistSterile Pharmaceutical Manufacturing | 12-Hour Day Shift (6:00 AM - 6:00 PM) | 2-2-3 ScheduleMake an Impact on Patient Safety and Product QualityAre you passionate about quality, problem-solving, and ensuring life-changing therapies are manufactured to the highest standards? We are seeking a Quality Assurance Specialist to serve as a critical quality partner within our sterile manufacturing operations.In this highly visible role, you will work side-by-side with Manufacturing, Quality Control, Engineering, and other cross-functional teams to ensure products are manufactured safely, efficiently, and in compliance with cGMP regulations. You'll have the opportunity to influence quality culture, lead investigations, drive continuous improvement initiatives, and provide real-time support on the production floor.This is an excellent opportunity for a quality professional who thrives in a fast-paced pharmaceutical environment and enjoys being actively involved in operations rather than working behind a desk.What You'll DoAs a Quality Assurance Specialist, you will be a trusted resource for manufacturing teams and a key contributor to operational excellence by:Providing real-time quality oversight and support for sterile manufacturing, filling, inspection, and packaging operations.Performing routine quality assessments of facilities, equipment, personnel practices, and GMP documentation.Partnering with production teams to troubleshoot process and equipment issues while ensuring compliance with quality standards.Reviewing and approving batch records, deviations, change controls, procedures, training documents, and investigation reports.Serving as the Quality representative during Root Cause Analysis (RCA) activities and supporting complex investigations.Participating in rapid response events and helping drive timely resolution of quality issues.Identifying trends, analyzing production data, and implementing solutions that improve efficiency, compliance, and product quality.Supporting CAPA activities and continuous improvement initiatives across the facility.Coaching and mentoring manufacturing personnel on GMP requirements, aseptic technique, and quality best practices.Contributing to technical writing activities, including procedures, reports, investigations, and quality documentation.Maintaining an active presence on the production floor to promote a strong culture of quality, compliance, and operational excellence.What We're Looking ForRequired QualificationsBachelor's degree in a scientific, engineering, technical, or related discipline, or equivalent combination of education and relevant experience.4+ years of experience in Quality Assurance, Quality Control, or pharmaceutical manufacturing operations.Experience working in a GMP-regulated environment.Strong understanding of cGMP regulations, quality systems, and documentation practices.Experience supporting investigations, deviations, and quality events.Proven ability to analyze data, troubleshoot manufacturing challenges, and solve complex problems.Strong technical writing and documentation review skills.Excellent communication and collaboration skills with cross-functional teams.A proactive mindset with a strong sense of ownership, accountability, and attention to detail.Preferred QualificationsExperience supporting sterile, aseptic, biologics, or parenteral manufacturing operations.Knowledge of CAPA, Change Control, Risk Assessments, and Quality Management Systems.Lean, Six Sigma, or Continuous Improvement experience.Certified Quality Auditor (CQA) or other quality-related certifications.Experience participating in regulatory inspections, audits, or validation activities.Why Join Us?Play a direct role in ensuring patients receive safe, high-quality therapies.Partner with talented teams across Manufacturing, Quality, Engineering, and Operations.Work in a collaborative environment that values innovation, continuous improvement, and professional growth.Gain exposure to complex sterile manufacturing processes and quality systems.Make a measurable impact on product quality, compliance, and operational performance.Work Environment & Physical RequirementsThis position is based within a sterile pharmaceutical manufacturing facility and requires frequent interaction within both classified and non-classified production areas. Candidates should be comfortable working in a GMP environment and wearing appropriate PPE and gowning required for sterile operations.The role requires:Extended periods of standing and walking on the production floor.Frequent bending, crouching, and movement throughout manufacturing areas.Ability to lift and carry up to 35 pounds.Ability to wear aseptic gowning and other required PPE.Regular use of computer systems for documentation review, data analysis, and technical writing.Schedule: 6:00 AM to 6:00 PM on a rotating 2-2-3 schedule, including alternating weekends.