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.

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