Quality Control Analyst I
Los Angeles, CA
Req ID 50557BR
Business Title
Quality Control Analyst I
Business
Global Quality
Sub-Business
BioScience Support
Country
US
State/Province
California
Location of Position
Los Angeles, CA
Shift_
Shift D
Job Description
•Conduct biological, chemical and physical analyses on pharmaceutical products (biologics and drugs) through all stages of the manufacturing process from incoming raw materials through finished good including at a minimum; in-process testing, final container testing, stability, and critical systems testing.
•Conduct biological, chemical and physical analyses on raw materials, stability, in-process samples and final products, and samples collected from systems monitoring programs, following controlled test procedures. Work under Supervision.
•Use sophisticated laboratory instrumentation and computer systems to collect and record data. May perform advanced assays requiring precise analytical skills and understanding of biological and chemical principles.
•Perform review of test data with application of GDP
•Complete all testing, including special project / protocol testing in a timely manner under direction of Project Leads and/or Supervisor
•Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR, and cGMP regulations
•Use Global LIMS or other computerized systems for entering and approving test results
•Actively contribute to a team setting within the laboratory and potentially with other work teams to increase efficiency, solve problems, generate cost savings, improve quality, and provide new product support.
•Ensure laboratory area is maintained in a GMP state at all times while following all EHS and 5S guidelines. Areas must be suitable for hand off to oncoming shifts
•Prepare and update SOPs as required under supervision
•Perform equipment maintenance and calibrations as required
•Support investigations of deviations and prepare exception documents, utilizing problem-solving tools as needed
•Drive Lean principles such as 5S throughout daily work activities
•Ensure personal training requirements are met and that training records are current.
Job Requirements
•Ability to handle multiple tasks concurrently and complete tasks in a timely manner.
•Computer literate and competent with a general knowledge of word processing and spreadsheets (such as Microsoft Office).
•Must be detail oriented, conscientious and have a high reading comprehension skill.
•Must have basic understanding of laboratory instrumentation and chemical handling
•Must have effective verbal and written communication skills
•Must be able to understand and apply cGMP/DPD, follow CTP/SOPs, and meet EHS requirements
•Must be able to learn new computer systems and programs in a timely manner.
•Bachelor's Degree in Chemistry or biological science with Analytical Chemistry or Laboratory coursework, with 0 - 2 years of relevant experience.
•Must be able to lift, push, pull and carry up to 25 lbs
•20/20 near vision required (corrected as acceptable)
•Must be able to recognize and distinguish among the colors red, yellow, and blue
•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. This may include additional hearing protection for loud areas
•No contact lenses may be worn in the work environment. No make-up, jewelry, nail polish or artificial nails may be worn in the work environment when applicable.
•In general, the position requires a combination of sedentary work, standing work, and walking around observing conditions in the facility
•May be required to enter a cold, wet environment and climb stairs or ladders to retrieve samples
•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 overtime as required.
•May be required to work in a confined area
•Primarily inside working conditions
•Some clean room and cool/hot storage conditions
•5% travel as applicable
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.
