Quality Assurance Specialist

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 **Quality Control (QC): Conduct routine and non-routine testing of raw materials, in-process samples, and finished products to ensure compliance with specifications.Manufacturing * Collaborate with production teams to identify and resolve quality issues during the manufacturing process.Batch * 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 * Perform lab testing and inspections, documenting results in accordance with standard operating procedures (SOPs).QA Process * 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.**Bachelor's degree in life sciences or related field.Must have strong experience in Batch Review/RecordsStrong LIMS ExperienceDeviation Oncology/Radiopharmaceuticals preferredProven 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.

Created: 2025-02-19