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
Skills Required
- Education: Doctorate OR Master's +2 years OR Bachelor's +4 years OR Associate's +8 years OR High School/GED +10 years of directly related experience
- Working knowledge of cGMP and site quality standards
- Experience reviewing and approving manufacturing procedures, validation protocols/reports, and lot disposition
- Experience leading investigations, CAPA, audits, and supporting internal/external inspections
- Ability to interact effectively with regulatory agencies
- Strong project management and organizational skills
- Strong computer literacy (word processing, presentations, databases, spreadsheets)
- Preferred: Degree in Microbiology, Biology, or Life Sciences
- Preferred: Environmental Monitoring and Microbial Identification experience
- Preferred: Critical Utilities monitoring and sampling techniques
- Preferred: Data trending, statistical evaluation, and visualization skills
- Preferred: Microbiological testing methods for cleanrooms and contamination control
- Preferred: Familiarity with regulatory standards (Annex 1, FDA Guidance, ISO‑14644‑1, USP)
- Preferred: Experience with Smartsheets, Spotfire, Veeva, LIMS, Maximo
- Preferred: Fully bilingual (English/Spanish)
What We Do
BioPharma Consulting JAD Group provides a complete portfolio of technical support and solutions for the FDA regulated industry. We deliver solutions with a flexible cost effective approach to meet your company’s needs. BPC JAD group is a company created to help our customers bridge the gap between their business strategy and results. Our mission is to help our clients succeed by partnering with them and providing value added business solutions on the validation, engineering and compliance fields. We will carry out our mission by creating a long-term partnership with our customers and provide reliable and cost effective technical solutions. BPC JAD Group objective is to deliver reliable tailored solutions; from providing consultation to becoming part of your staff. We will develop customized frameworks to help our customers unlock the hidden value in their plants, facilities, equipment and people with an optimal integration of resources regulations and technology.
