Quality Assurance Senior Specialist

2 weeks ago

Columbus, Ohio, United States Cardinal Health Full time

Overview of Quality Assurance at Cardinal Health

Quality Assurance plays a crucial role in developing and enforcing quality protocols, procedures, and systems to ensure that products and services adhere to regulatory standards and specifications.

Role of the Quality Assurance Specialist

The Quality Assurance Specialist (QAS) is responsible for conducting thorough quality reviews and making approval/release decisions within a regulated pharmaceutical manufacturing environment. This position ensures that the facility produces safe, effective, and reliable products.

Key Responsibilities

  • Oversee CGMP documentation related to product release, equipment, material controls, laboratory processes, packaging, and production.
  • Establish and report metrics concerning products and processes as required by the Regional Quality Manager.
  • Ensure compliance with 21 CFR 212 (CGMP) during manufacturing operations.
  • Manage documentation quality (control, retention, and archival) to support CGMP activities.
  • Collaborate with operations to enhance quality systems and CGMP compliance.
  • Conduct product release activities in accordance with CGMP standards.
  • Monitor and manage CAPA investigations, ensuring timely closure or escalation when necessary.
  • Perform aseptic reviews in collaboration with operations and document findings.
  • Report quality system issues to the Regional Quality Manager and escalate discrepancies as needed.

Qualifications

  • 2-4 years of relevant experience preferred.
  • Bachelor's degree in a related field or equivalent experience preferred.
  • Proficiency in MS Excel and MS Word.
  • Strong interpersonal skills and attention to detail.
  • Experience in a cGMP environment is preferred.
  • Project management experience is a plus.

What to Expect at This Level

  • Utilize working knowledge of concepts and principles to perform diverse tasks.
  • Engage in projects of moderate complexity.
  • Identify solutions to various technical challenges and take appropriate actions.
  • Exercise judgment within defined parameters.
  • Receive general guidance and detailed instructions for new projects.
  • Work will be reviewed for sound reasoning and accuracy.

Compensation and Benefits

Cardinal Health offers a comprehensive benefits package, including:

  • Medical, dental, and vision coverage.
  • Paid time off.
  • Health savings account (HSA).
  • 401k savings plan.
  • Flexible spending accounts (FSAs).
  • Short- and long-term disability coverage.
  • Work-life resources and healthy lifestyle programs.
  • Paid parental leave.

Cardinal Health is committed to fostering an inclusive workplace that values diversity of thought, experience, and background. We encourage all qualified applicants to consider joining our team.

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