Specialist QA

BioPharma Consulting JAD Group

13h

About The Position

The Quality Assurance Specialist provides quality oversight and support for regulated manufacturing operations, ensuring compliance with current Good Manufacturing Practices (cGMP), regulatory requirements, and internal quality systems. This role performs QA review, approval, and leadership activities under minimal supervision and serves as a key quality representative across manufacturing, validation, automation, facilities, and New Product Introduction (NPI) initiatives.

Requirements

Doctorate degree; OR Master’s degree with 2+ years of directly related experience; OR Bachelor’s degree with 4+ years of directly related experience; OR Associate degree with 8+ years of directly related experience; OR High School Diploma or GED with 10+ years of directly related experience.
Strong project management and organizational skills.
Ability to independently manage assignments from initiation to completion.
Proven experience leading cross-functional teams.
Strong influencing, negotiation, and decision-making skills.
In-depth knowledge of manufacturing, quality assurance, quality laboratories (QAL), validation, and process development.
Experience interacting with regulatory agencies and supporting inspections.
Advanced data trending, analysis, and evaluation skills.
Ability to assess compliance issues and recommend effective solutions.
Strong written and verbal communication, facilitation, and presentation skills.
Proficiency with word processing, presentation, database, and spreadsheet applications.
Ability to work independently and effectively interact with all organizational levels.

Nice To Haves

Experience supporting New Product Introduction (NPI) activities.
Strong background in Change Control, Validation, Factory Acceptance Testing (FATs), and Process Performance Qualifications (PPQs).
Hands-on experience with GMP manufacturing environments.

Responsibilities

Review and approve Manufacturing Procedures (MPs).
Review and approve process validation protocols and reports, including IQ/OQ/PQ and PPQs.
Participate as the Quality representative on incident triage teams.
Review and approve Environmental Characterization reports.
Provide quality release and oversight of sanitary utility systems.
Review and approve planned incidents and deviations.
Represent Quality Assurance on New Product Introduction (NPI) teams.
Lead and approve deviation investigations, nonconformance (NC) investigations, and CAPA records.
Lead and participate in site audits and regulatory inspections.
Own, maintain, and improve site quality procedures and quality program documentation.
Serve as designee for the QA Manager on the Change Control Review Board (CCRB).
Review and approve quality risk assessments.
Support automation, facilities, and environmental monitoring programs.
Review and approve work orders and EMS/BMS alarms.
Review and approve change controls in accordance with quality system requirements.
Perform lot disposition activities and authorize product release for shipment.
Demonstrate and uphold company values and leadership practices.