Quality Assurance Specialist

1w1 week ago

Sharp Services

Bethlehem, US · Full-time · $70,000 – $95,000

About this role

The Quality Assurance Specialist ensures cGMP compliance and adherence to SOPs through the review and approval of compliance documentation. This role focuses on maintaining high standards by scrutinizing batch records, components, labels, and analytical reports. It upholds quality across pharmaceutical processes.

Day-to-day responsibilities include reviewing pre-execution and post-execution batch records for cGMP compliance. Approve components, bulk drug product, labels for production, and Analytical Reports/COAs to meet quality standards. Prepare Annual Product Review reports in compliance with FDA and EU regulations.

Participate in or lead internal and supplier audits, reviewing results to resolve deviations. Assist in writing audit findings, generating CAPAs, and investigating deviations, discrepancies, and non-conformances. Work with internal staff to meet timelines in a clean, safe environment and attend regular meetings.

Review and update SOPs, policies, and processes to align with cGMP, FDA, and authority regulations. Provide timely communication of quality issues to management and assist in training on cGMPs and SOPs. Prepare investigation reports with recommendations for corrective and preventative actions.

Requirements

Bachelors’ Degree, Associates Degree, or equivalent in science or technical related field preferred
3-5 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 to interact with team, peers, management, and external contacts
Ability to interpret and implement cGMPs, FDA & DEA Regulations and CFRs
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 components and bulk drug product to ensure proper quality and compliance standards
Review and approve labels for release to production
Review and approve Analytical Reports/COAs to ensure proper quality and compliance
Prepare Annual Product Review (APR) reports in compliance with FDA and EU regulations
Review and approve Distribution Instructions, Return Instructions, and Third-Party Instructions
Participate/lead in internal audits and/or supplier audits and ensure resolution of deviations
Participate in investigations, deviations, discrepancies, and non-conformance of materials and processes