Quality Assurance Specialist Job at Discover International, San Jose, CA

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  • Discover International
  • San Jose, CA

Job Description

Discover International are currently partnered with a leading Pharmaceutical Company based around 30 Minutes from San Jose, CA who are seeking a Quality Assurance Specialist to be work fully onsite. This role will be an 18 Month Contract.

**Please only consider applying if you are located within this area and happy to work onsite**

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 per regulatory standards.
  • LIMS (Laboratory Information Management System): Utilize LIMS to manage and track laboratory data, ensuring all information is accurate and up-to-date.
  • Lab Work: Perform lab testing and inspections, documenting results in accordance with standard operating procedures (SOPs).
  • QA Process Oversight: Assist in the development, implementation, and maintenance of 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 related field.
  • Must have strong experience in Batch Review/Records
  • Strong LIMS Experience
  • Deviation
  • Oncology/Radiopharmaceuticals preferred
  • Proven experience in quality assurance and quality control in a manufacturing or laboratory setting.
  • Familiarity with regulatory guidelines and industry standards (e.g., cGMP practices, FDA).
  • Strong attention to detail and excellent problem-solving skills.

Job Tags

Contract work,

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