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Quality Assurance Specialist Jobs

Company

EPM Scientific

Address Kentucky, United States
Employment type FULL_TIME
Salary
Category Biotechnology Research,Pharmaceutical Manufacturing
Expires 2023-06-11
Posted at 1 year ago
Job Description

We are seeking an experienced Quality Assurance Specialist to join our team. The ideal candidate will have a strong background in quality assurance within the pharmaceutical industry, with a focus on GMP compliance. The QA Specialist will be responsible for ensuring that all products are manufactured, tested, and released in accordance with established specifications, standards, and procedures.


Key Responsibilities:

  • Perform internal audits and ensure that corrective and preventive actions are implemented in a timely manner.
  • Participate in the development, implementation, and maintenance of quality-related procedures and policies.
  • Provide support during regulatory inspections and customer audits.
  • Ensure compliance with current Good Manufacturing Practices (cGMP) regulations and guidelines.
  • Investigate deviations, out-of-specification results, and other quality-related issues and ensure that appropriate corrective and preventive actions are taken.
  • Provide guidance and support to manufacturing and laboratory personnel on quality-related issues.
  • Review and approve batch records, validation protocols and reports, and other quality-related documentation.
  • Maintain the company's quality system and ensure that all quality-related documentation is accurate, complete, and up-to-date.


Qualifications:

  • Bachelor's degree in a scientific discipline (e.g., Chemistry, Biology, Pharmacy) or equivalent combination of education and experience.
  • Strong communication and interpersonal skills.
  • Ability to work independently and as part of a team.
  • Minimum of 1-5 years of experience in quality assurance in the pharmaceutical industry.
  • Strong knowledge of current Good Manufacturing Practices (cGMP) regulations and guidelines.
  • Experience with conducting internal audits and investigating deviations and out-of-specification results.
  • Experience with reviewing and approving batch records, validation protocols and reports, and other quality-related documentation.


If you are a highly motivated and detail-oriented individual with a passion for quality and compliance, we encourage you to apply for this exciting opportunity. We offer a competitive salary, comprehensive benefits package, and the opportunity to work with a talented and dedicated team of professionals.