What are the responsibilities and job description for the Quality Assurance Specialist position at Discover International?
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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