Job Description

SUMMARY

Join a quality-driven team where you’ll serve as the on-the-floor QA presence supporting manufacturing, packaging, and warehouse activities. You’ll perform sampling and in-process checks, provide room and equipment clearance, review documentation, and help ensure compliance with cGMP standards. This role offers the chance to work closely with operations while building strong, transferable QA skills.

RESPONSIBILITIES

• Act as QA support during manufacturing and packaging processes.
• Perform sampling of raw and packaging materials, water, gas, in-process and finished products, and environmental monitoring. Submit samples to QC or third-party labs with full documentation.
• Collect cleaning verification samples (e.g., TOC, product residue, microbiological swabs) and coordinate submission to QC.
• Clear rooms and equipment prior to batch operations.
• Conduct in-process testing and AQL inspections to support production activities.
• Receive and record external samples within quality systems.
• Assist with document control: issue training records, batch records, logbooks, and protocols; archive controlled copies.
• Carry out quality testing and release of raw materials, packaging materials, in-process, and finished products.
• Review executed batch records, warehouse logs, logbooks, and forms for accuracy and compliance.
• Support development and review of SOPs, forms, deviations/investigations, change controls, CAPAs, and qualification protocols/reports.
• Review supporting documentation from warehouse, metrology, engineering, and validation groups to ensure compliance with procedures and regulations.
• Partner with cross-functional teams to resolve quality issues promptly.
• Promote Good Documentation Practices (GDP) and compliance with internal standards.
• Provide training to new hires and complete additional duties as needed.

QUALIFICATIONS

• Bachelor’s degree preferred, or equivalent combination of education and experience.
• Prior QA experience in a cGMP-regulated pharmaceutical or biologics environment is strongly preferred.
• Experience working with controlled documentation in a regulated setting.
• Strong interpersonal skills with the ability to work independently and within cross-functional teams.
• Clear written and verbal communication skills in English.
• Strong organizational skills, detail-oriented, with the ability to prioritize effectively.
• Computer proficiency, including MS Word, Excel, and spreadsheet tools.
• Ability to interpret technical information and produce accurate, complete documentation.
• Physical requirements: extended computer use, extended standing/walking in operational areas, and occasional lifting up to 25 lbs.

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