Quality Assurance Specialist

The Quality Assurance Specialist ensures cGMP compliance and adherence to SOPs through the review and approval of compliance documentation. 

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 components and bulk drug product 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.
• Participate/Lead in internal audits and/or supplier audits per schedule and review the results of audits to ensure resolution of any noted deviations.
• Assist to write up of audit findings and reports and generation of CAPAs related to audit findings.
• Provide timely communication of quality issues to management as needed.
• Participate in investigations, deviations, discrepancies, technical problems, procedures, complaints and non-conformance of materials and processes.
• 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 cGMP standards, FDA and all competent authority regulations and requirements.
• Prepare written reports of investigations with recommendations for corrective and preventative actions to problems and changes to procedures to ensure high quality is the company standard.
• Maintain accurate, detailed records of work performed.
• Work with internal staff to meet scheduled requirements in a timely manner.
• Is accountable for maintaining 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.

• 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 is required to communicate with the 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.

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.

While performing the duties of this job, the employee is frequently required to stand, walk, and sit and regularly required to talk or hear.  Employee is occasionally required to walk, use hands for tasks requiring manual dexterity, handle or feel and reach with hands and arms. The employee must occasionally lift and/or move up to 50 pounds.

Specific vision abilities required by this job include color vision.