QC Chemistry Associate II CAPS

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Company: Central Admixture Pharmacy
Job Posting Location: Irvine, California, United States
Functional Area: Quality
Working Model: Onsite
Days of Work: Thursday, Wednesday, Friday, Tuesday, Monday
Shift: 5X8
Relocation Available: No
Requisition : 4067

B. Braun Medical Inc., a leader in infusion therapy and pain management, develops, manufactures, and markets innovative medical products and services to the healthcare industry. Other key product areas include nutrition, pharmacy admixture and compounding, ostomy and wound care, and dialysis. The company is committed to eliminating preventable treatment errors and enhancing patient, clinician and environmental safety.

B. Braun Medical is headquartered in Bethlehem, Pa., and is part of the

B. Braun Group of Companies in the U.S., which includes

B. Braun Interventional Systems, Aesculap and CAPS.

Globally, the

B. Braun Group of Companies employs more than 64,000 employees in 64 countries. Guided by its Sharing Expertise philosophy,

B. Braun continuously exchanges knowledge with customers, partners and clinicians to address the critical issues of improving care and lowering costs. To learn more about

B. Braun Medical, visit

CAPS, part of the

B. Braun Group of Companies in the U.S., is the nation's largest network of outsourcing admixture pharmacies, has been delivering high-quality, same-day, admixture services and solutions to hospitals and outpatient facilities for more than 28 years. Along with the nation’s largest 503A sterile injectable outsourcing network, CAPS offers industry-leading batch compounding on a national scale through three 503B registered outsourcing facilities.

With experience, capacity, and a passion for safety, CAPS is your 503B solution.

Position Summary:

Performs routine functions/analysis as required by the laboratory in compliance with CAPS, and cGMP specifications. The analyst prepares test samples and performs tests according to the standard operating procedures.

Responsibilities:
Essential Duties

• Perform routine analysis of finished product, raw material or environmental samples according to established specifications and procedures using various laboratory apparatus under minimal supervision of senior staff.
• Interprets and applies specifications and operating procedures when carrying out both monitoring and testing responsibilities.
• Records data in controlled notebooks, controlled data sheets, validated spreadsheets and/or LIMS including all computational tasks and completes analysis report forms. Maintains neat and legible records and promptly and accurately inputs data into LIMS.
• May perform routine laboratory maintenance and instrument upkeep as required. Prepares standards or test reagents according to established procedures and specifications.
• Follows cGMPs, GLPs, SOPs, USP and FDA guidelines in all appropriate functions and notifies supervisor and/or lead of any observed discrepancies.
• Prepare media, reagents, test samples and equipment as required.
• Responsible for the general cleanliness and appearance of the lab by keeping laboratory equipment, supplies and environment in good operational condition.
• Proficient or become proficient in Environmental Monitoring techniques.
• Proficient or become proficient in Sterility Test, Bioburden, and Growth Promotion.
• Proficient or become proficient in Bacterial Endotoxins testing using Kinetic-Turbidimetric assay.
• Keep inventory of laboratory supplies for routine testing and special projects.

Expertise:
Knowledge & Skills

• Understand aseptic technique.
• Knowledge of basic chemistry principles in the quality field.
• Must have a good understanding of documentation procedures and GMPs for the health care industry.
• Good communication and interpersonal skills.
• Ability to work independently or in a team. Good technical and troubleshooting skills.
• Must be able to use computers, calculators, diagnostic test equipment and precision…