Quality Specialist

Job Description

Our pharmaceutical client is seeking a Quality Specialist to support commercial external manufacturing operations for biologic drug products produced at a key Contract Manufacturing Organization (CMO). This individual will serve as a quality representative supporting aseptic manufacturing operations, investigations, quality systems activities, and ongoing quality oversight for commercial products manufactured in prefilled syringe and vial presentations.

The ideal candidate will bring hands-on Quality Assurance experience in aseptic manufacturing environments and be comfortable partnering directly with CMO personnel, internal quality teams, and cross-functional stakeholders to ensure compliance, resolve quality issues, and support day-to-day commercial manufacturing activities.

Key Responsibilities Commercial CMO Quality Oversight Serve as the primary quality support resource for a commercial manufacturing site producing sterile biologic products. Provide ongoing oversight of quality activities occurring at the CMO. Maintain strong partnerships with internal stakeholders and external manufacturing teams. Participate in site visits and support onsite quality presence at the manufacturing facility as needed.

Investigations & Nonconformance Management Review CMO investigations and provide quality feedback, comments, and resolution support. Support oversight of deviations, nonconformances, and investigation activities. Author internal nonconformances and quality documentation when required. Drive timely closure of quality events through effective root cause analysis and risk assessment.

Change Control & Quality Systems Perform quality assessments of change controls and manufacturing changes. Support assessment memos and quality impact evaluations. Prepare and review quality documentation supporting commercial manufacturing activities. Ensure activities comply with GMP requirements, internal procedures, and regulatory expectations.

Manufacturing & Compliance Support Support commercial aseptic manufacturing operations for prefilled syringe and vial products. Provide QA support for manufacturing operations, floor activities, and issue resolution. Maintain visibility into quality trends, risks, and open actions. Partner cross-functionally to ensure product quality and inspection readiness.

Skills and Requirements

Bachelor's degree in a scientific discipline. 5+ years of pharmaceutical Quality Assurance experience. Experience supporting biologic and/or sterile pharmaceutical products. Direct aseptic manufacturing experience in QA, manufacturing, operations, or training. Experience managing or supporting investigations, deviations, and nonconformances. Strong understanding of GMP regulations and quality systems. Experience reviewing and assessing change controls. Ability to work independently while influencing cross-functional stakeholders. Strong written and verbal communication skills. Experience providing quality oversight for Contract Manufacturing Organizations (CMOs). Experience supporting commercial manufacturing programs. Experience with sterile injectable products, prefilled syringes, and vial manufacturing. Experience supporting monoclonal antibody products. Experience authoring assessment memos and quality impact assessments. Experience working directly with external manufacturing partners. Familiarity with quality systems such as TrackWise, Veeva, COMET, or similar platforms. Experience supporting regulatory inspections and audit readiness activities.

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal employment opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment without regard to race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to View email address on click.appcast.io.