Quality Control Analyst II
Hayward, CA
Req ID 50738BR
Business Title
Quality Control Analyst II
Business
Global Quality
Sub-Business
BioScience Support
Country
US
State/Province
California
Location of Position
Hayward, CA
Shift_
1st
Job Description
Conduct biological, chemical and physical analyses on pharmaceutical products and medical devices through all stages of the manufacturing process from incoming raw materials to finished goods, and environmental monitoring programs.
•Conduct biological, chemical and physical analyses on raw materials, initial, in-process and final products, and samples collected from the environmental monitoring programs at manufacturing facility. Work under some supervision.
•Perform microbial and particulate monitoring of clean rooms throughout the facility; including personnel monitoring of gowns and gloves. May be responsible for overseeing daily work flow of assigned area.
•Testing as required supporting microbial identifications, bioburden analysis, biological indicators, growth promotion, water, and sterility groups. Will be required to read microbial plates and interpret test results. Some troubleshooting will be required.
•Support and potentially lead continuous improvement projects in the QM Laboratories such as 5S, Kaizen, Just-do-it's, and VIP.
•Train laboratory personnel on Lean modules, lean concepts, and lean philosophy where appropriate.
•Provide support in preparation of Business Unit and Management Review slides. Help facilitate the logistics associated with the business unit review.
•Serve as Mentor to Quality Control Analyst (QCA) I positions. Provide training and work direction for QCA I positions as required.
•Perform review of test data, which includes overall documentation practices. Perform release functions in LIMS or other computerized systems.
•Use sophisticated laboratory instrumentation and computer systems to collect and record data.
•Perform advanced biological and chemical assays requiring precise analytical skills and understanding of biology and chemistry principles.
•Complete all testing, including special project / protocol testing in a timely and appropriate manner.
•Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR and cGMP regulations.
•Investigate deviations and write non conformance and lab investigation reports.
•Participate in functions involving teams, which impact production, increase efficiency, solve problems, generate cost savings and improve quality.
•Perform laboratory and manufacturing audits as required. Audit and update, as required, plant SOPs.
•Perform equipment maintenance and calibrations as required.
•Support execution of validations for lab equipment, lab methods, or facility projects.
•May be required to generate, execute, and summarize special laboratory studies.
•Drive Lean principles such as 5S throughout daily work activities.
•Ensure personal training requirements are met and that training records are current.
•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.
•Demonstrated working knowledge of assays/equipment in functional area.
•Computer literate and competent with a working knowledge of word processing and spreadsheets (such as Microsoft Office).
•Must be detail-oriented, conscientious, and responsible.
•Capable of applying some decisions-making to problem-solve technical, compliance, or operational problems as assigned.
•Effective interpersonal communication. Must have effective verbal and written communication skills.
•Can demonstrate the ability to guide people, encourage teamwork, and teach assays.
•Working knowledge of applicable CTP/SOPs, EHS requirements, FDA Regulations, application of cGMP/GDPs.
•Some project management skills. Good leadership, organization, and time management skills.
•Demonstrated knowledge of Lean and/or Six Sigma. Lean Instructor training or equivalent is strongly desired.
•Must be able to learn new computer systems and programs in a timely manner.
•Must be able to lift, push, pull and carry up to 25 lbs.
•Must be able to work in controlled environments requiring special gowning. Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet, and body.
•No make-up, jewelry, nail polish or artificial nails may be worn in the work environment when applicable.
•Will work around chemicals such as alcohol, acids, buffers and celite that may require respiratory protection.
•May be required to work or be assigned to a different shift to meet business needs. Must be willing to work off shift hours.
•Must be able to work supplemental hours as necessary to complete work commitments.
•May be required to work in a confined area
•Primarily inside working conditions
•Some clean room and cool/hot storage conditions
Job Requirements
Bachelors Degree in Chemistry, or Biological Sciences with Analytical Chemistry or Laboratory coursework, with 2-5 years experience, or Masters Degree in Chemistry, or Biological Sciences, with 0-3 years experience.
Doing Work that Matters
Baxter provides its employees with comprehensive compensation and benefits. To view additional opportunities at Baxter and to learn more about the company, please visit our Web site at company website. EOE M/F/D/V.
