Specialist QA

Job Description

Job Description

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