Alcami is looking for a Senior Quality Assurance Specialist, GMP Manufacturing to ensure quality and compliance with regulatory requirements and internal procedures in a fast-paced environment.
Requirements
- Aseptic parenteral manufacturing.
- Grade C gowning.
- GMP and Annex 1 experience.
- 20/20 corrected vision for Visual Inspector qualification.
Responsibilities
- Performs quality review and approval of documents, data, protocols, and/or reports.
- Performs GMP document creation and issuance (batch records, logbooks, forms, etc.).
- Performs visual inspection of parenteral product (requires qualification).
- Performs internal quality audits and/or inspections.
- Supports client audits and inspections, and regulatory inspections.
- Maintains quality databases.
- Assists with implementation and supports quality systems, including but not limited to, operations support, batch review and approval, training, vendor management, and overall regulatory inspectional readiness.
Other
- 100% on-site position.
- Bachelor’s degree in Chemistry, Biology, or related field with 10+ years of GMP related experience, or Master’s degree in related field.
- Minimum five years of related work experience.
- Rarely may be requested to travel to support other Alcami sites.
- Serves as an effective member of the Quality Assurance team and may serve as a mentor to others in area of expertise.
