QA Project Specialist

Job Summary

The QA Project Specialist plays a critical role in supporting quality assurance activities and cross-functional project execution within a 503B outsourcing facility. This position ensures that QA systems and projects are executed in compliance with FDA 503B regulations, cGMP standards, and internal procedures. The QA Project Specialist will coordinate quality-related initiatives such as investigations, validations, change controls, document control, and process improvement projects.

• Quality Systems & Documentation: Support the management and execution of CAPAs, deviations, investigations, and change controls.
• Assist in maintaining and updating SOPs, batch records, and controlled quality documents.
• Participate in document review, approval workflows, and archival processes in the document control system.

• Project Coordination: Collaborate with cross-functional teams (Production, QC, Engineering, Supply Chain) to support the implementation of quality-related projects.
• Track and report project timelines, deliverables, and quality metrics to ensure compliance and completion.
• Assist with validation documentation, including protocols, reports, and summary documents (equipment, process, cleaning, and computer systems).

• Compliance & Inspection Readiness: Ensure all project documentation and QA records are audit-ready and aligned with FDA and cGMP expectations.
• Support internal audits and external regulatory inspections (FDA, DEA, State Board of Pharmacy).
• Participate in mock audits and inspection preparation activities.
• Identify and propose quality improvements in procedures, documentation, and systems.
• Support implementation of QA process enhancements aligned with operational goals and compliance standards.

• Bachelor’s degree in Life Sciences, Chemistry, Pharmacy, or a related field.
• 2–4 years of experience in Quality Assurance or QA project coordination in a pharmaceutical or 503B manufacturing environment.
• Working knowledge of cGMP, FDA 503B guidance, USP 797, 800, and 85 requirements.
• Strong written and verbal communication skills, with excellent attention to detail.
• Proficient with document control systems and project tracking tools (e.g., Qualio, Master Control, MS Project, Excel).

• Experience in sterile compounding, aseptic manufacturing, or regulated drug production.
• Knowledge of validation life cycle and quality risk management principles.
• Familiarity with electronic quality management systems (eQMS) and controlled documentation practices.

• 3-5 years working in related industry

• Collaborate with different teams to coordinate timelines to meet production schedule.
• Support cGMP production facility activities.

• Good hand-eye coordination.
• Ability to repeatedly sit and stand for periods of time.
• Ability to lift up to 30 lbs.

• QA Manager or as assigned

• Must wear clean scrubs when in the facility.

Job Type: Full-time

Pay: $75,000.00 - $85,000.00 per year

• Health insurance
• Paid time off

• This position is expected to be on-site, between the hours of 8am to 4:30pm, Monday through Friday. Are you able to meet these expectations?