Demo

Quality Assurance Professional

Discover International
San Jose, CA Full Time
POSTED ON 4/26/2025
AVAILABLE BEFORE 5/22/2025

Discover International is excited to partner with a leading Pharmaceutical Company seeking a Quality Assurance Specialist to join their team. This is a fantastic opportunity to work fully onsite in a dynamic environment on a contract basis for 18 months.

Note : Only applicants located in the region around San Jose, CA, and willing to work onsite will be considered.

Key Responsibilities :

  • Quality Control (QC) : Conduct routine and non-routine testing of raw materials, in-process samples, and finished products to ensure compliance with specifications.
  • Manufacturing Support : Collaborate with production teams to identify and resolve quality issues during the manufacturing process.
  • Batch Release : Review and approve batch records for product release, ensuring all manufacturing and quality control steps have been completed according to regulatory standards.
  • LIMS (Laboratory Information Management System) : Utilize LIMS to manage and track laboratory data, ensuring all information is accurate and current.
  • Lab Work : Perform lab testing and inspections, and document results in accordance with standard operating procedures (SOPs).
  • QA Process Oversight : Assist in developing, implementing, and maintaining quality assurance protocols to ensure compliance with regulatory requirements.
  • CAPA (Corrective and Preventive Action) : Lead CAPA investigations to identify root causes of non-conformances, implement corrective actions, and track effectiveness.

Qualifications :

  • Bachelor's degree in life sciences or a related field.
  • Strong experience in Batch Review / Records.
  • Robust knowledge of LIMS.
  • Experience with Deviation management.
  • Background in Oncology / Radiopharmaceuticals preferred.
  • Proven track record in quality assurance and quality control in a manufacturing or laboratory environment.
  • Familiarity with regulatory guidelines and industry standards (e.g., cGMP practices, FDA).
  • Exceptional attention to detail and strong problem-solving skills.
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