The Role
Lead and approve GMP and manufacturing process documentation, validation protocols (PPQ, cleaning), deviations, investigations, CAPAs, site audits, NPI, and quality programs to ensure cGMP compliance in biopharma manufacturing.
Summary Generated by Built In
QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you’ll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA.
Responsibilities:
Qualifications:
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.
- Experienced working in biopharmaveutical industry, quality organization supporting deviations, validation reports, qualifications, investigations.
- 5 years of experienced in a highly regulated environment.
- Experience in Quality and Compliance, experience with validation protocols and reports for clean utilities, manufacturing processes, cleaning processes, equipment, computerized systems, change control records, deviations, etc.
- Experience in biological processes
- Strong knowledge and hands-on experience with Aseptic manufacturing processes
- Change Control Experience
- Proven experience with NPI, Change Control, FATs, Validation, PPQs, and Cleaning Validation
- Manufacturing and laboratory experience required
- Demonstrated expertise in GMP documentation practices, including protocol/report review, investigations, and regulatory submissions
- Strong understanding of manufacturing, distribution, QA/QC/QAL, validation, and process development activities
- 8hrs Monday to Friday (Administrative), available nonstandard as needed.
Skills Required
- Bachelor's degree in Science, Engineering, Physics, Biology, Chemistry or related field
- Minimum 5 years' experience in a highly regulated (biopharmaceutical) environment
- Experience in Quality and Compliance supporting deviations, investigations, validations, and qualifications
- Experience with validation protocols and reports for clean utilities, manufacturing processes, cleaning processes, equipment, and computerized systems
- Hands-on experience with aseptic manufacturing processes
- Experience with Change Control processes
- Proven experience with NPI, FATs, Validation, PPQs, and Cleaning Validation
- Manufacturing and laboratory experience
- Experience with environmental monitoring and sanitary utility systems compliance
- Demonstrated expertise in GMP documentation practices including protocol/report review, investigations, and regulatory submissions
- Strong understanding of QA/QC/QAL, validation, and process development activities
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The Company
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
