Responsibilities:
- Review, approve, and maintain manufacturing process documentation (MPs) in compliance with cGMP requirements
- Review, approve, and ensure accuracy, completeness, and traceability of GMP documentation, including protocols, reports, investigations, and quality records
- Approve process validation protocols and reports, including PPQs and cleaning validation documentation
- Participate as Quality representative on incident triage teams, ensuring timely and compliant decision-making
- Review and approve planned incidents, deviations, and nonconformances, ensuring appropriate risk assessment and documentation
- Approve Environmental Characterization and environmental monitoring reports
- Release and maintain compliance of sanitary utility systems
- Represent Quality Assurance on New Product Introduction (NPI) teams
- Lead and document investigations, root cause analyses, and CAPA development
- Lead and support site audits, including internal, external, and regulatory inspections
- Own, maintain, and continuously improve site quality program procedures
- Serve as QA Manager designee on the local Change Control Review Board (CCRB)
- Review and approve risk assessments and mitigation strategies
- Support automation systems, including review of validation and change documentation
- Support facilities, utilities, and environmental compliance programs
Qualifications:
- Possess a BS in Science, Engineering, Physics, Biology, Chemistry or related fields.
- Experience in Change Control, Documentation Review, Validation & PPQ
- Administrative Shift
Skills Required
- Bachelor of Science degree in Science, Engineering, Physics, Biology, Chemistry, or a related field
- Experience with change control
- Experience with documentation review
- Experience with validation and PPQ
- Availability for an administrative shift
What We Do
The Quality Consulting Group is a pharmaceutical, biotechnology, food and medical device specialty consultant that supports the manufacturing industry; services are provided in multiple areas including: Regulatory Compliance, Quality Operations, Validation, Manufacturing, Training and Technical Support. Starting, as individual services provider since 2002, Quality Consulting Group has supported clients implementing the latest standards such as Validation Guidance, ICH Guidelines, and Process Excellence and Risk Management tools. Quality Consulting Group has provided expertise in such areas as: business, operational, quality, regulatory and manufacturing strategies; organizational structures; management controls; manufacturing and quality systems methodologies and practices; compliance programs; and accuracy reviews; FDA, EMEA and other regulatory matter
