QC Associate III - CAPS - Part-time

Central Admixture Pharmacy Services, Inc.


QC Associate III - CAPS

US-CA-Irvine

Job ID: 2023-22556
Type: Regular Full-Time
# of Openings: 1
Category: Quality
CAPS Micro Irvine Facility

Overview

CAPS®, 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.
CAPS is part of the B. Braun Group of Companies in the U.S.

Responsibilities

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.
• 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, Bioburden, and Growth Promotion.
• Proficient or become proficient in Bacterial Endotoxins testing using Kinetic-Turbidimetric assay.
• Proficient or become proficient in Microbial Identification using Vitek II System.
• Keep inventory of laboratory supplies for routine testing and special projects.
• Keep track of equipment calibration log and coordinate with Metrology for calibration services.
• Validate laboratory test results for accuracy and completeness.
• Initiate investigation for Out-of-Specification test results.
• Responsible for releasing of qualified media used in pharmacies and Micro laboratory.

Expertise: Knowledge & Skills

• Understand aseptic technique.
• Knowledge of basic microbiology principles in the quality field.
• Must have a good understanding of documentation procedures and GMPs for the health care industry.
• Must have a basic understanding of statistics, sample plans and AQL levels.
• 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 measuring equipment.
• Must have organizational planning skills.
• Excellent communication skills.
• Must be able to get along with the other people and work as a team member.
• Must be able to follow instructions and follow tasks through to completion.
• Must be flexible/adaptable.
• Must be able to schedule tasks and meet deadlines.
• Must be able to manage one's time and have a sense of urgency.

Target Based Range

23.51 - 28.21

Qualifications

Expertise: Qualifications - Experience/Training/Education/Etc

Required:

• Bachelors degree and 3-4 years related experience
• Or High School Diploma/GED and 4-5 years related experience
• Basic understanding of Microbiology; basic knowledge in technical area as required by the specific QC lab.
• Basic knowledge of good analytical and laboratory techniques, basic knowledge of cGMPS’s, GLP’s, SOP’s, USP, and FDA requirements.
• Apply specific skills as required by the technical specialty(s) within the department.
• Frequent travel required.

Desired:

• Science degree and direct experience in specific laboratory work

While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to handle or feel and reach with hands and arms. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 20 pounds.

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Additional Information

Responsibilities: Other Duties:

The preceding functions have been provided as examples of the types of work performed by employees assigned to this position. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed in this description are representative of the knowledge, skill, and/or ability required. Management reserves the right to add, modify, change or rescind the work assignments of different positions due to reasonable accommodation or other reasons.

Physical Demands:

• Ability to stand and/or sit for long periods of time.
• Ability to reach, grasps, stoop, pull and perform repetitive motion procedures.
• Ability to lift up to 20 lbs.

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Work Environment:

• Indoors, cleanroom, working environment limited to a small area, wearing protective cleanroom attire, tolerating controlled temperatures and loud noise.

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually moderate.

What We Offer

B. Braun offers an excellent benefits package, which includes healthcare, a 401(k) plan, and tuition reimbursement. To learn more about B. Braun and our safety healthcare products or view a listing of our employment opportunities, please visit us on the internet at www.bbraunusa.com. Through its Sharing Expertise® initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services.

Notices

Equal Opportunity Employer Veterans/Disabled

All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.

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