Title: Quality Control Analyst I
Duration:- 6+ Months Extendable contract
Location:- Hayward, CA
Pay Rate Range:- $25.00- $30.00 on W2Summary
• Microbiology and Sterilization subject matter expert. Responsible for results in terms of product quality and conformance to Sterilization and Microbiology regulations and Client quality policies. Flexibility to perform other duties as assigned or as business needs require.
• Works and communicates effectively and professionally with others inside and outside the company.
• Weekend work may be required as needed to meet production timeline schedules.
Essential Duties and Responsibilities
• Perform routine sampling and process samples in support of the Microbiology department. (Sterilization, Microbiology, and Environmental Controls).
• Documents and processes samples in a Laboratory environment. • Enters data into the Laboratory Information Management System.
• Manage the activities of Microbiology and Sterility Assurance with responsibility for product quality, performance, and safety results.
• Maintain data integrity and ensure compliance with company standard operating procedures (SOPs) and worldwide regulatory requirements.
• Provide a technical resource for evaluating alternate sterilization technologies, contamination control, and process monitoring.
• Understands and assures conformance to regulations in the Microbiology laboratory and Sterilization (EO and Gamma).
• Support Client QMS improvement initiatives related to Sterilization and Clean room processes, including Risk Management updates.
• May be required to write exceptions, nonconformance reports (NCRs), and CAPAs as needed utilizing TrackWise. Qualifications (To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. List knowledge, skills, and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.)
• Ability to handle multiple tasks concurrently and complete tasks in a timely manner.
• Effective organizational skills and ability to plan and suggest resolutions to technical problems.
• Demonstrates some knowledge of assays/equipment in functional areas. Computer literate and competent with a general knowledge of word processing and spreadsheets (such as Microsoft Office).
• Proficient use of laboratory equipment and tools. Must be detail-oriented, conscientious, and responsible. Must have effective verbal and written communication skills. Some knowledge of applicable CTP/SOPs, EHS requirements, and FDA Regulations application of CGMP/GDPs.
• Must be able to learn new computer systems and programs in a timely manner.
Education and/or Experience
• B.S. degree in Microbiology, Biology, or related science
• 2-5 years of experience or Master’s degree in biological sciences with 0-3 years’ experience, preferably in the pharmaceutical or medical device •
Last updated on Oct 24, 2023