Alcami is looking for a Quality Assurance Specialist - Packaging to ensure quality and compliance with applicable regulatory requirements in a fast-paced environment, supporting the delivery of reliable solutions for transformative medicines.
Requirements
- Relevant GMP experience required.
- Experience in Environmental monitoring and critical utilities preferred for sterile operations.
- Strong knowledge of regulations and SOPs applicable to area of responsibility and keeps abreast of new regulations and regulatory guidance in areas of expertise.
- Good computer skills and knowledge of Microsoft Office products.
- Ability to act as technical consultant.
Responsibilities
- Performs quality review and approval of complex documents, all types of data, protocols, and/or reports.
- Supports quality floor audits and/or floor inspections.
- Supports for client and regulatory agency audits and inspections.
- Provides quality evaluation and release of support materials, products, equipment and facilities as required.
- Maintains quality databases and may perform analysis and trending.
- Develops quality SOPs or other quality documents and/or reports as needed.
- Provides Quality oversite for the site specific Quality Management Systems including Investigations, Corrective Actions, Change control, etc.
Other
- 100% on-site position.
- Friday - Sunday, 7:00am - 7:30pm & every other Monday, 7:00am – 3:30pm.
- Three 12-hour shifts every week plus One 8-hour shift every other week.
- Good written and oral communication skills.
- Up to 5% travel required.
