Quality Assurance Specialist
Sharp Packaging Solutions, part of UDG Healthcare plc
Summary
The Quality Assurance Specialist ensures product and process quality, cGMP compliance and adherence to Sharp SOPs through the review and approval of compliance documentation. The Quality Assurance Specialist applies critical thinking and problem solving, working across departments to promote a Right First Time approach to products, processes and documentation.
Job description
Essential Duties and Responsibilities
- Review and approve pre-execution and post-execution batch records to ensure cGMP compliance and adherence to SOPs.
- Review and approve component and bulk drug product QC reports to ensure proper quality and compliance standards are met.
- Review and Approve labels for release to production, ensuring proper quality and compliance standards are met, as required.
- Review and approve Analytical Reports/COAs to ensure proper quality and compliance standards are met.
- Prepare Annual Product Review (APR) reports in compliance with FDA and EU regulations.
- Review and approve Distribution Instructions, Return Instructions and Third-Party Instructions.
- Provide timely communication of quality issues to management as needed.
- Participate in component, product, and process non-conformance investigations, CAPA and change control.
- Assist in training employees in cGMPs, SOPs, or quality issues as necessary.
- Review and update SOPs, policies and processes regularly to ensure all quality standards are in compliance with applicable cGMPs and industry standards.
- Maintain accurate, detailed records of work performed.
- Work collaboratively with operations, project management, validation, QC and other departments meet compliance requirements and production deadlines.
- Maintain a clean, orderly and safe work environment.
- Participate actively in regular meetings.
- Other duties as assigned.
Qualifications
- Bachelors’ Degree, Associates Degree, or equivalent in science or technical related field preferred.
- 3 years relevant work experience in a cGMP environment.
- Demonstrated ability to work independently, handle multiple tasks simultaneously, negotiate and meet critical timelines, strong attention to detail and excellent organizational skills.
- Excellent oral and written communication is required to communicate with the team, peers, management, and external contacts.
- Ability to interpret and implement cGMPs, FDA & DEA Regulations.
- Strong working knowledge of personal computers and Microsoft Office Products, including Word, Project, Excel, and Access.
Requirements
- Bachelors’ Degree, Associates Degree, or equivalent in science or technical related field preferred.
- 3 years relevant work experience in a cGMP environment.
- Demonstrated ability to work independently, handle multiple tasks simultaneously, negotiate and meet critical timelines, strong attention to detail and excellent organizational skills.
- Excellent oral and written communication is required to communicate with the team, peers, management, and external contacts.
- Ability to interpret and implement cGMPs, FDA & DEA Regulations.
- Strong working knowledge of personal computers and Microsoft Office Products, including Word, Project, Excel, and Access.
Benefits
- Hybrid work arrangement
- On-site presence 3 days/week
Company overview
Sharp Packaging Solutions, operating as part of UDG Healthcare plc, is a global leader in contract pharmaceutical packaging and clinical services with a heritage spanning more than 70 years. The company specializes in providing comprehensive packaging solutions and clinical trial supply services to pharmaceutical and biotechnology clients, supporting products from Phase I trials through commercial launch and lifecycle management. With a team of over 2,200 professionals, Sharp operates state-of-the-art GMP facilities across the United States, United Kingdom, Belgium, and the Netherlands. Their services encompass commercial packaging, clinical trial packaging, sterile manufacturing, serialization solutions, and clinical IRT services. As a division of UDG Healthcare, Sharp leverages global reach and extensive industry expertise to deliver reliable, compliant packaging solutions that ensure patient safety and product integrity throughout the pharmaceutical supply chain.