The Quality Assurance Specialist performs a wide range of responsibilities to support the site’s Quality Assurance program with minimal supervision. This role ensures compliance with internal procedures, regulatory expectations, and industry standards while providing oversight of manufacturing, facilities, utilities, and quality systems. The specialist serves as a key QA representative across cross‑functional teams, leads investigations and audits, and supports the release of products and systems.
FUNCTIONS
- Review and approve product Master Plans (MPs).
- Approve process validation protocols and reports for manufacturing processes.
- Review and approve Environmental Characterization reports.
- Review and approve Work Orders and EMS/BMS alarms.
- Review and approve risk assessments and planned incidents.
- Approve nonconformance investigations and CAPA records.
- Approve change controls and ensure compliance with quality system requirements.
- Provide lot disposition and authorize lots for shipment.
- Serve as QA representative on New Product Introduction (NPI) teams.
- Lead and support site investigations, ensuring timely and compliant closure.
- Lead internal audits and support external audit readiness.
- Own and maintain site quality program procedures.
- Act as designee for QA Manager on local Change Control Review Board (CCRB).
- Support automation, facilities, and environmental monitoring programs.
- Release sanitary utility systems in accordance with quality requirements.
- Participate in incident triage teams and provide QA decision‑making support.
- Initiate and lead cross‑functional teams to resolve quality or operational issues.
- Collaborate with internal and external stakeholders to ensure alignment with quality and regulatory expectations.
- Provide guidance and support to less experienced team members.
SKILLS
- Strong project management and organizational skills; ability to drive tasks to completion.
- Ability to lead, influence, negotiate, and collaborate across functions and levels.
- Strong knowledge of manufacturing, distribution, QA, validation, and process development processes.
- Ability to evaluate compliance issues and make sound quality decisions.
- Experience interacting with regulatory agencies.
- Advanced data trending, evaluation, and analytical skills.
- Excellent written and verbal communication, facilitation, and presentation skills.
- Proficiency in word processing, spreadsheets, databases, and presentation software.
- Ability to work independently and manage multiple priorities effectively.
Requirements
EDUCATION & EXPERIENCE REQUIREMENTS
- Doctorate OR
- Master’s degree + 2 years of directly related experience OR
- Bachelor’s degree + 4 years of directly related experience OR
- Associate degree + 8 years of directly related experience OR
- High School/GED + 10 years of directly related experience.
PREFERRED QUALIFICATIONS
- Experience performing batch record (EBR) review, approval, and reconciliation.
- Experience providing QA oversight of manufacturing operations.
- Experience managing events, investigations, and quality decision‑making.
Benefits
- 3rd Shift
- 12 hour shift 5pm-5:30 am: Night shift Rotating coverage (including weekends and holidays)
- 6-month contract
Skills Required
- Education: Doctorate OR Master's degree + 2 years OR Bachelor's degree + 4 years OR Associate degree + 8 years OR High School/GED + 10 years of directly related experience
- Experience approving master plans, process validation protocols/reports, risk assessments, change controls, CAPAs, and lot dispositions
- Ability to lead and conduct internal audits and support external audit readiness
- Experience leading site investigations, root cause analysis, and timely compliant closure
- Experience interacting with regulatory agencies
- Strong project management, organizational, facilitation, presentation, and communication skills
- Advanced data trending, evaluation, and analytical skills
- Proficiency with word processing, spreadsheets, databases, and presentation software
- Ability to work independently, manage multiple priorities, and mentor less experienced team members
- Willingness/ability to work 3rd shift 12-hour nights (5:00pm-5:30am), rotating coverage including weekends and holidays
- Experience performing batch record (EBR) review, approval, and reconciliation
- Experience providing QA oversight of manufacturing operations
- Experience managing events, investigations, and quality decision-making
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.
