Manufacturing Quality Specialist

The Manufacturing Quality Specialist is responsible for ensuring compliance with cGMP regulations, company policies, and customer expectations by supporting manufacturing operations through documentation review, quality event management, and process oversight. 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.

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