B. Braun

QC Chemistry Associate IV

Job Locations US-CA-Irvine
Requisition ID
2018-11816
Company
B. Braun Medical Inc
# of Openings
1
Category
Quality
Position Type
Regular Full-Time
Shift
7:00am - 3:30pm
Site
Irvine, CA

Overview

With a nationwide sales team and several manufacturing locations, B. Braun Medical has become a leading full-line supplier of healthcare products and services in the U.S. The company is committed to delivering innovative products and services with unmatched quality, superior technology, and cost-effectiveness, while maintaining environmental responsibility. Through its "Sharing Expertise®" initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services. B. Braun employs over 4,500 people in the USA. B. Braun Medical Inc. began its operations in the USA in 1957. Initially, the company manufactured and sold disposable plastic syringes. During the 1980s and early 1990s, the company undertook several expansions and enlarged its product line of disposable medical devices. With the acquisition of McGaw, Inc. in 1997, including Central Admixture Pharmacy Services, Inc. (CAPS®), B. Braun dramatically broadened its product lines and services to U.S. customers.

 

U.S. Facilities and Operations:

 

Supporting product sales are a network of nationwide marketing and manufacturing locations. Bethlehem, Pennsylvania, is home to the U.S. Corporate Headquarters along with the marketing offices of the Hospital, Outpatient Markets (OPM), Renal Therapies, Vascular Interventional, International, and OEM Divisions. Central Admixture Pharmacy Services, Inc.(CAPS®) is also managed from this location. The nearby Allentown, Pennsylvania, facility manufactures Needle-free products, IV Safety Catheters, Anesthesia Systems, Introducers, Pharmacy Admixture products. Vascular products including Right Heart Catheters and Interventional Accessories are also manufactured in Allentown. The Irvine, California facility produces IV Solutions, Basic and Specialty Nutrition, Drug Delivery, and BTC products. Infusion Pump Systems are manufactured in Carrollton, Texas and IV administration and IV and Irrigation sets are produced in the Dominican Republic.

Responsibilities

Position Summary:

Perform advanced and sometimes routine laboratory analysis of In-Process, finished product, raw material, stability samples and environmental monitoring according to established specifications and procedures using wet chemistry techniques or various laboratory apparatus and instruments (e.g. HPLC, UV/Visible Spectrophotometer, FTIR, TOC, pH meter etc.) in compliance with B. Braun, cGMP, GLPs, SOPs, USP, EP and FDA guidelines.

Responsibilities: Essential Duties

  • Interpret and apply specifications, operating procedures, and record/review data in controlled notebooks, data sheets, validated spreadsheets, and/or LIMS following and meeting Good Documentation Practices (GDPs).
  • Perform routine qualification, calibration, and maintenance of laboratory instruments.
  • Perform routine laboratory discrepancy investigations, and document/write investigation summaries.
  • Prepare documentation (protocols, change control requests, qualifications etc.) for validation/qualification of new laboratory instruments, test methods/process validations/verifications.
  • Prepare analytical standards and reagents according to established procedures and specifications.
  • Identify and report inconsistencies in documentation to Lead and/or Supervisor and solve/update the documentation.
  • In case of any observed discrepancies, initiate and follow through OOS/DSMS investigation to completion.
  • Responsible for the general cleanliness by keeping laboratory work area in order.
  • Perform proper hazardous waste removal. Follow laboratory safety regulations.
  • Conduct inventory audits and proper disposal of expired reagents, standards, and chemicals used in the laboratory.
  • Responsible for hands on training of new associates on laboratory testing procedures and instruments operation.

Expertise: Knowledge & Skills

  • Basic knowledge of cGMPs, GLPs, SOPs, USP, EP and FDA requirements, good analytical and laboratory techniques.
  • Computer literate on Microsoft Office (Word/Excel), SAP (DSMS), MES, LIMS, B.DOCS.

Qualifications

Expertise: Qualifications - Experience/Training/Education/Etc

Required:

  • High school graduate or equivalent.
  • Without a 4 year related college degree: 5 or more years related experience.
  • With a 4 year related college degree: 2-3 years related experience.

Desired:

  • BS or BA degree in a science related field, Chemistry preferred.

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.

 

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 Equal Opportunity Employer Minorities /Women/ Veterans/Disabled

Through its “Sharing Expertise®” initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services.

Other

Responsibilities: Other Duties:

  • Other duties as assigned.

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:

  • The employee must occasionally lift and/or move up to 20 pounds. The employee is regularly required to work with chemicals, and wear PPE (lab coat, gloves, safety glasses, safety shoes, respirator mask, etc.) while performing the duties of this job.

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:

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.

 

IN2017

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