Quality Assurance Specialist

Sharp Services•Bethlehem, PA

29d•Hybrid

About The Position

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.

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.

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.