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. 

Essential Duties and Responsibilities include the following. Other duties may be assigned.

• 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

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential

functions.

• 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.

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is frequently required to stand, walk, use hands to finger, handle or feel, reach with hands and arms and stoop, kneel, or crouch. The employee is regularly required to sit and talk or hear. Prolonged periods of sitting at a desk and working on a computer. Must be able to traverse the facility on a frequent basis.

Environmental Conditions

The noise level in the work environment is usually quiet to moderate.

This position is afforded the benefit of working in a hybrid arrangement. As a member of Sharp Clinical’s Quality team, this role must have an on-site presence, averaging at least three (3) days on site on a weekly basis. Business needs may require this position to be onsite more than three (3) days per week with or without notice. Working remotely must be done in a dedicated, quiet workspace with minimal distractions and/or interruptions.