Job Description

SUMMARY

Join a quality-focused team ensuring products and processes meet rigorous standards. In this role, youll coordinate deviation investigations, support audits and inspections, own quality event tracking within an electronic QMS, and help drive continuous improvements. Youll collaborate across functions on CAPAs, change controls, supplier qualification, and annual product reviewsbuilding hands-on experience in a regulated manufacturing environment.

RESPONSIBILITIES

• Lead/coordinate investigations for deviations, LIRs, OOS events, and non-conformances; document findings and track actions to closure.
• Draft and execute effective CAPAs that address true root cause and prevent recurrence; verify effectiveness over time.
• Evaluate and process change controls with risk assessments and stakeholder coordination.
• Prepare for and support internal/external audits and inspections; help compile evidence and respond to observations.
• Manage quality events and controlled documentation in the electronic QMS (e.g., change controls, deviations, OOS, complaints).
• Log, triage, and coordinate product complaint handling per established procedures.
• Compile quality metrics and trends; present insights during regular quality reviews (biweekly/monthly).
• Assemble Annual Product Review/Annual Product Quality Review (APR/APQR) reports with cross-functional inputs.
• Support vendor/supplier qualification activities and maintain required records.
• Communicate with suppliers/vendors for qualification documentation and regulatory filing needs.
• Champion good documentation practices (GDP) and site-wide continuous improvement initiatives.
• Perform additional quality tasks as assigned to meet operational needs.

QUALIFICATIONS

• Bachelors degree preferred (or equivalent combination of education and experience).
• Experience in Quality Assurance within a cGMP-regulated pharmaceutical/biologics manufacturing environment preferred.
• Familiarity with controlled documents and electronic QMS tools.
• Clear, concise written and verbal communication; strong interpersonal skills for cross-functional teamwork.
• Highly organized with strong attention to detail; able to manage multiple priorities and deadlines.
• Ability to interpret technical information and produce accurate, complete documentation.
• Capable of working at a computer for extended periods and traversing operational areas as needed; able to occasionally lift up to 25 lbs.

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