Curia - Albuquerque, NM

posted 3 days ago

Full-time - Mid Level
Albuquerque, NM
Professional, Scientific, and Technical Services

About the position

Curia provides global contract research and manufacturing services to the pharmaceutical and biotechnology industries. Join our talented workforce, where a commitment to excellence and a customer focused attitude is everything. We pursue excellence because our work has the power to improve patients' lives with the pharmaceuticals we develop and manufacture. Manufacturing Quality Assurance is responsible for coordinating all necessary activities to support daily product manufacturing and product lot release. Additionally, MQA is the primary Quality contact for all internal customers with respect to product, process, and material issues involving site operations.

Responsibilities

  • Supervise the Manufacturing Quality Assurance activities, to include on the floor batch record review and Quality Assurance oversight of manufacturing processes.
  • On call to answer quality questions from Quality Assurance and Production employees as needed.
  • Provide manufacturing and Quality Assurance technical expertise to internal departments.
  • Provide training on cGMPs to the QA group and Production as needed.
  • Provide support on validation report closure, change control, investigation approval and other QA systems related issues.
  • Support strategic/global projects by working with all plant management groups on new products, changes to products, and services to achieve a consistent approach to Quality as needed.
  • Support quality and compliance process improvements and goals for the sites using current regulations and best-demonstrated practices as needed.
  • Assist in effective and efficient continuous quality and cost improvement efforts as needed.
  • Hire, train and develop MQA staff and conduct Performance Reviews to assure highly effective, team-oriented contributors.
  • Develops and support departmental strategic goals to assure the highest quality standards and regulatory compliance.
  • Serves as resident QA expert in support of all manufacturing quality assurance functions (product release, product inspection, batch record reviews, compliance) and resolution of issues on the production floor.

Requirements

  • BS or BA in Science, Chemistry or Biology.
  • Minimum of 3-5 years of progressively greater responsibilities in the pharmaceutical products/medical services industry, including QA, Regulatory, Operations, Project, Technical, and Laboratory experience.
  • Including 3 years in Quality Assurance or Regulatory Compliance Management.
  • Including 3 years in an aseptic/sterile product facility required.
  • Demonstrated understanding of laboratory, manufacturing, packaging, regulatory, compliance, and quality assurance requirements for biological and drug product manufacturing.

Nice-to-haves

  • Experience strongly preferred working with third-party contract manufacturing in the Pharmaceutical industry.

Benefits

  • Generous benefit options (eligible first day of employment)
  • Paid training, vacation and holidays (vacation accrual begins on first day of employment)
  • Career advancement opportunities
  • Education reimbursement
  • 401k program
  • Learning platform
  • And more!
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