Trenton - Manufacturing Quality Specialist

This role requires expertise in upstream and downstream biologics processes, quality systems, and regulatory requirements to ensure the highest standards of product quality and compliance.

Salary: $90,000 -$100,000 experience depending

Responsibilities:

• Perform inspection, sampling, and testing (where applicable) on incoming materials, packaging components, and returned goods following detailed written procedures.
• Ensure smooth flow of raw material and critical material testing through routine follow-up with internal and external laboratories.
• Perform cleaning and sanitization of ISO 7 areas and ISO 5 laminar flow hoods per written procedures.
• Assign and verify expiry dates and retest dates for all GMP raw materials through vendor COA and/or in-house COA.
• Review and release raw materials and critical materials for use in manufacturing.
• Author and review batch records, SOPs, and associated forms/formats required for the manufacturing process.
• Support manufacturing teams by reviewing executed batch records for both upstream and downstream processes.
• File and manage change controls, deviations, CAPAs, and other quality system documentation for the manufacturing department.
• Conduct investigations into critical/major quality events using root cause analysis tools such as 5 Whys and 6M methodology.
• Participate in daily meetings with upstream and downstream manufacturing teams to identify and address documentation requirements.
• Meet weekly with QA to ensure timely closure of quality management system (QMS) events.
• Review documentation supporting batch, laboratory, warehouse, metrology, engineering, and validation activities to ensure completeness and compliance with cGMP requirements.
• Review documentation supporting quality event system investigations (e.g., change controls, deviations, out-of-specifications, complaints) prior to final disposition.
• Perform quality assurance walk-through audits of manufacturing, laboratory, and warehouse areas to ensure compliance with cGMPs and company procedures.
• Ensure quality events are appropriately cross-referenced and included in batch documentation before final disposition.
• Provide backup support for other Quality Assurance Specialist responsibilities as needed.
• Assist in cross-functional projects to resolve quality and manufacturing issues, implementing corrective and preventive actions (CAPAs) in a timely manner.
• Support manufacturing processes during critical campaigns, including up to 10% wet lab work as needed.
• Ensure compliance with all company policies and industry standards.

Experience/Qualifications:

• Bachelor’s degree in Biological Sciences, Engineering, or a related technical field.
• 3-7 years of quality assurance experience in a cGMP pharmaceutical or biopharmaceutical manufacturing environment.
• Strong working knowledge of cGMP regulations (21 CFR 210/211).
• Technical expertise in upstream and downstream biologics manufacturing processes, including cytokines and monoclonal antibody production.
• Experience with QMS investigations, including CAPAs, deviations, and change controls.
• Familiarity with quality event investigation tools such as 5 Whys and 6M methodology.
• Strong communication skills, both written and verbal.
• Excellent organizational skills, detail-oriented, and ability to prioritize assignments effectively.
• Ability to work independently and collaboratively in cross-functional teams.
• Proficiency in Microsoft Office applications.
• Experience authoring technical reports and creating document templates.
• Ability to utilize technical information to ensure clarity, accuracy, and completeness in documentation.