Principal Quality Specialist, GMP Manufacturing
Overview
You will own quality oversight for GMP manufacturing at Alcami, driving compliance across aseptic parenteral operations. You will review and approve documents, data, and protocols while leading audits for clients and regulators. As a Principal Quality Specialist, you will mentor junior staff and act as the technical quality backup for site management. This role demands deep expertise in Annex 1 regulations and visual inspection, with a focus on batch record issuance and quality system maintenance. You will play a critical part in ensuring regulatory inspectional readiness at a 100% on-site facility in Raleigh.
What You'll Do10
- 1Review and approve GMP documents, data, protocols, and reports with full ownership of quality decisions.
- 2Create and issue GMP batch records, logbooks, and forms, ensuring compliance with SOPs and Annex 1 guidelines.
- 3Perform visual inspection of parenteral products, maintaining qualification and accuracy in a Grade C gowning environment.
- 4Conduct internal quality audits and floor inspections, identifying deviations and recommending corrective actions.
- 5Host client and regulatory agency audits, acting as the quality liaison and ensuring smooth inspectional flow.
- 6Maintain quality databases and trend analysis, using Microsoft Office tools to report on key quality metrics.
- 7Develop and update SOPs and other quality documents, aligning with current GMP regulations and company policies.
- 8Mentor junior quality staff, providing guidance on complex compliance topics and technical decision-making.
- 9Serve as backup to site Quality Management, making technical quality decisions during their absence.
- 10Complete all cGMP training on schedule, ensuring personal and team compliance with regulatory requirements.
Requirements10
- 113+ years of GMP experience with a Bachelor's degree in Chemistry, Biology, or related field, or 5+ years with a Master's degree.
- 2Hands-on aseptic parenteral manufacturing experience, including Grade C gowning and visual inspection qualification.
- 3Strong knowledge of GMP regulations and Annex 1 guidelines, with the ability to apply them in daily operations.
- 4Proven experience in quality auditing, both internal and external, with a track record of hosting regulatory inspections.
- 5Expertise in Microsoft Office products and quality database management, including trend analysis and reporting.
- 6Excellent written and verbal communication skills, capable of consulting with clients and regulatory agents.
- 7Ability to act independently and negotiate effectively, solving complex quality issues with minimal supervision.
- 8Demonstrated mentoring and training skills, with the ability to develop and deliver quality training programs.
- 9Visual acuity and physical capability to perform visual inspections and stand for extended periods.
- 10Up to 5% travel required for client or regulatory site visits.
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