Quality Assurance Specialist

Description

SHINE Technologies is a fast-paced radiopharmaceutical company that expects significant growth. The Quality Assurance (QA) Specialist will support the Isotopes Quality Assurance department. by supporting production record review and disposition, the internal audit program, and review of cGMP documents including validation protocols, analytical and microbiological data and help maintain the electronic quality management system. This position will also support the Management’s quality initiatives through the creation of appropriate reports and presentations and will support all on site QA functions at the commercial manufacturing site. The Quality Assurance Specialist will primarily be on first shift but requires flexibility to adjust hours as needed for support on second shift during the latter half of the week.

Duties And Responsibilities

Specific duties and responsibilities include, but are not limited to:

• Review and disposition production batch records.
• Review and disposition documentation related to validation.
• Support and execute records and actions related to the Corrective Action and Preventive Action, Change Control, and Effectiveness Check programs.
• Perform and assess investigations related to process and procedure deviations with applicable impact/risk assessment, root cause analysis, and trend analysis.
• Review Microbiological and QC Analytical Data to ensure it meets all test requirements and data is sound.
• Perform raw material inspection, review, and disposition.
• Participate in the internal audit program.
• Support the document control activities to ensure SOPS, Forms and Work Instructions are kept current.
• Support training activities through assignments in ACE (electronic Quality Management System) and conducting group training as needed.
• Provide reports to support the Quality Management Review initiatives.
• Support remediation actions for identified negative trends in operations and quality control data.
  
  

Requirements

• B.S. degree in scientific discipline including biology, chemistry, engineering, radiochemistry, or physics.
• Previous experience of 2-4 years in pharmaceutical or medical device company is required.
• Experience in reviewing and approving all documentation related to running an effective Quality Management System.
• Experience in reviewing QC analytical and microbiological data.
• Previous experience performing internal audits.
• Familiarization with applicable quality regulations related to pharmaceutical and radiopharmaceutical manufacturing.
• Adequate computer skills/knowledge to perform required job functions.
• Moderate physical activity. Requires handling of average weight objects up to 40 pounds.
  
  

Eligibility for employment is conditioned on the applicant’s ability to qualify for access to information subject to U.S. Export Controls. Additionally, applicant’s eligibility may be conditioned based upon meeting the Nuclear Regulatory Commission requirements for access to Safeguards Information, which typically requires a pre-employment drug screen, fingerprinting and criminal background check.

SHINE values diversity in all its forms as a critical component of innovation, which is fundamental to our success. Every member of the SHINE community benefits from the talents and experiences of our peers, from the mutual respect we exercise, and from the responsibility we take for our actions.

SHINE Technologies is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.

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