Job Description

The Specialist QA performs a wide range of Quality Assurance activities under minimal supervision to support GMP operations. This role is responsible for reviewing, approving, and overseeing quality systems, environmental monitoring programs, investigations, audits, and lot disposition. The Specialist QA serves as a key QA representative across cross‑functional teams, ensuring compliance with cGMP, regulatory expectations, and site quality standards.

Key Responsibilities

• Review and approve product manufacturing procedures (MPs).
• Approve process validation protocols and reports for manufacturing processes.
• Participate in incident triage teams and provide QA oversight.
• Approve Environmental Characterization reports.
• Release sanitary utility systems.
• Approve planned incidents and change controls.
• Represent QA on New Product Introduction (NPI) teams.
• Own and maintain site quality program procedures.
• Serve as QA designee on local CCRB.
• Review and approve Work Orders and EMS/BMS alarms.
• Approve non‑conformance (NC) investigations and CAPA records.
• Provide lot disposition and authorize lots for shipment.
• Lead investigations and support root cause analysis activities.
• Lead site audits and support internal/external inspections.
• Evaluate compliance issues and escalate quality, supply, or safety risks to senior management.
• Support GMP building Environmental Monitoring processes.
• Generate Environmental Monitoring (EM) and Critical Utilities (CU) trend reports.
• Participate or lead Risk Assessments for sampling sites in GMP areas.
• Provide environmental control assessments for change controls, deviations, and audit processes.
• Participate in Environmental Control Network, Aseptic Council, or Contamination Control Network.
• Present EM/CU data at Quality System forums and Management Review meetings.
• Ensure facilities, equipment, materials, processes, and products comply with cGMP and applicable regulations.

Skills

• Strong project management and organizational skills.
• Ability to lead and influence cross‑functional teams.
• Strong knowledge of manufacturing, distribution, QA, validation, and process development.
• Ability to interact effectively with regulatory agencies.
• Strong computer literacy (word processing, presentations, databases, spreadsheets).
• Ability to work independently and collaborate across multiple levels.
• Ability to evaluate compliance issues and recommend corrective actions.

Requirements

Required Education

• Doctorate, OR
• Master’s + 2 years of directly related experience, OR
• Bachelor’s + 4 years of directly related experience, OR
• Associate’s + 8 years of directly related experience, OR
• High School/GED + 10 years of directly related experience

Preferred: Microbiology, Biology, or Life Sciences

Preferred Qualifications

• Environmental Monitoring & Microbial Identification
• Critical Utilities monitoring
• Sampling techniques and equipment
• Data trending, statistical evaluation, and visualization
• Microbiological testing methods for cleanrooms and controlled environments
• Aseptic behavior and contamination control
• Facility cleaning and disinfection practices
• Regulatory standards: Annex 1, FDA Guidance, ISO‑14644‑1, USP
• Software tools: Smartsheets, Microsoft Office, Spotfire, Veeva, LIMS, Maximo
• Fully bilingual (English/Spanish) with strong communication skills

Benefits

• 6-month contract with possible extension
• Administrative shift