Overview
Quality Assurance Professional Jobs in San Jose, California, USA at Discover International
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.
Title: Quality Assurance Professional
Company: Discover International
Location: San Jose, California, USA
Category: Quality Assurance – QA/QC (Quality Control / Manager, QA Specialist / Manager, Quality Technician/ Inspector, Quality Engineering)
