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Pharmaceutical Quality Assurance Specialist

2 months ago

Coral Springs, Florida, United States Actalent Full time
Job Title: Pharmaceutical Quality Assurance Specialist

Job Summary:

We are seeking a highly skilled Pharmaceutical Quality Assurance Specialist to join our team at Actalent. As a key member of our quality assurance team, you will be responsible for ensuring the quality and compliance of our pharmaceutical products.

Key Responsibilities:

  • Review and verify batch records and documentation to ensure compliance with good documentation practices (GDP), product specifications, and regulatory requirements.
  • Collaborate with cross-functional teams to ensure timely delivery of corrections, QA review, and disposition responsibilities.
  • Compile and review documentation for batch review and release, and oversee the status of batches to ensure all QA batch disposition deadlines are met.
  • Review analytical reports to ensure products, materials, components, and intermediates meet company standards and regulatory requirements.
  • Review test results generated in support of testing of raw materials, in-process, finished products, and stability samples.
  • Review environmental monitoring data, microbiology, and cleaning testing results.
  • Review quality events, incidents, and deviations related to manufacturing processes and laboratory testing.
  • Ensure compliance with SOPs and Safety Guidelines in a cGMP environment.
  • Provide support during regulatory and internal audits.
  • Track data and records review indicators for internal quality metrics and annual product review.
  • Identify and participate in internal quality improvement initiatives.

Requirements:

  • Strong knowledge of GMP regulations and guidelines.
  • Excellent communication and collaboration skills.
  • Attention to detail and ability to work in a fast-paced environment.
  • Ability to work in a lab environment and follow safety protocols.

What We Offer:

Actalent is a global leader in engineering and sciences services and talent solutions. We offer a dynamic and supportive work environment, competitive compensation and benefits, and opportunities for professional growth and development.

Actalent is an Equal Opportunity Employer:

We are committed to diversity, equity, and inclusion in the workplace. We welcome applications from qualified candidates of all backgrounds and perspectives.