Quality Lab Associate I - Endotoxin

Baxter International • Marion, NC

81d • $64,000 - $88,000

About The Position

This is where your creativity addresses challenges. Conduct microbiological analysis on raw materials, solution, and water samples following approved Standard Operating Procedures in an accurate and timely manner. Within Quality, every role makes a difference. Products that Baxter makes are shipped worldwide for patients in need. Whether it's building a new process from scratch or facing a never-before-seen production hurdle, individuals within Quality are given the trust and opportunity to bring creativity to the table. The mission of Baxter is to save and sustain lives. This mission is embedded into everything we do. This means if there is a decision to be made where quantity and quality are at odds, we will always choose quality. Our patients come first, always.

Requirements

• B.S. degree in Microbiology, Biology, or related science.
• Minimum 2 years of experience or Master's Degree in biological sciences with relevant experience, preferably in the pharmaceutical or medical device industry.
• Computer literate/knowledge of Microsoft office applications (Word, Excel).
• Proficient in quality based computer systems such as LIMS, POMS, Endoscan-V software, Sampler Sight Pharma, and AS400.
• Attention to detail and ability to prioritize multiple tasks.
• Proficient in the operation of laboratory instrumentation and equipment such as laminar flow hoods, micro-pipettors, pH meters, analytical balances, and instruments used to perform particulate matter and endotoxin testing.
• Good documentation skills and knowledge of GDPs (Good Documentation Practices).
• Knowledge of aseptic sampling and testing techniques and microbiological testing according to FDA, cGMP, GLPs and USP testing methodology.
• Must be able to communicate effectively with supervisors and peers.
• Must be experienced in executing general microbiology procedures.
• Must be able to stand for extended periods.
• Must be able to lift 50 lbs.

Responsibilities

• Prepare samples and perform endotoxin testing on raw materials, solution, and water for bioburden.
• Perform particulate matter testing on solution.
• Perform daily pH meter, balance, and pipette verification.
• Perform daily Honeywell automated temperature checks and manual temperature monitoring.
• Perform peptidoglycan and gel clot testing as needed.
• Manage reagent inventory.
• Generate monthly trend reports.
• Calibration of micro-pipettes, analytical balance, water bath, dry heat bath, depyrogenation ovens, light obscuration particle counters and spectrophotometer.
• Responsible for daily lab upkeep including cleaning, glassware washing and depyrogenation, supply replenishment, syringe and endotoxin prep.
• Assist in method validation and protocol testing as needed.
• Sustain a clean and safe work environment utilizing 6S principles.
• Operate laboratory instrumentation and equipment such as laminar flow hoods, micro-pipettors, pH meters, analytical balances, and instruments used to perform particulate matter and endotoxin testing.
• Write and revise Standard Operating Procedures and review job-related technical documents.
• Perform laboratory and manufacturing audits as required.
• Train others to perform microbiological testing/tasks.
• Serve as mentor to Quality Lab Associate I (QLA I) positions.
• Serve as a back-up to Quality Lab Associate III (QLA III) in their absence.
• Write exceptions, nonconformance reports (NCRs) and CAPAs as needed utilizing TrackWise.

Benefits

• Medical, Dental and Vision coverage.
• 160 hours of Paid Time Off and Paid Holidays.
• 401K match.
• Employee Stock Purchase Program.
• Paid Parental Leave.
• Tuition Reimbursement.

What This Job Offers

• Industry: Computer and Electronic Product Manufacturing
• Education Level: Bachelor's degree