QC Process Control Assoc I
Location:
Irvine , California
Posted:
October 20, 2017
Reference:
2017-10922
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:

Under supervision, responsible for performing in-process inspections, process monitoring, quality support and investigations/resolution. Process monitoring includes AQL sampling, performing line clearances and line control. Provide quality support by performing tasks as assigned by Process Control Management.
Responsibilities: Essential Duties
  • Perform manufacturing process verifications to ensure compliance with operating procedures and specifications (for example, verify proper line clearance, compliance with operating and inspection procedures, operation of equipment per validated parameters, equipment calibration, operator training, compliance with gowning and clean room procedures, etc.).
  • Perform in-process AQL sampling not limited to particulate matter inspections, verification of product labeling, leak testing, and overall product quality to ensure conformance with process, procedures, and product release specifications.
  • Provide a continuous quality presence on assigned manufacturing line.
  • Report quality deviations to Process Control Lead/Supervisor in a timely manner.
  • Provide support for quality investigations and resolution of quality issues such as documenting events or investigation results per applicable procedures.
  • Provide sound quality decisions as need arises, i.e., product segregations, line stops, and escalation to lead/supervisor as necessary.
  • Perform all activities with a working knowledge of company procedures and specifications.
  • Provide support to the manufacturing operation in all areas related to quality
  • Maintain Instrument Usage and Calibration Logs based on instrument usage during the preparation and testing of samples.
  • Demonstrate a quality mind-set capable of assessing and resolving discrepancies on the manufacturing lines.
  • Maintain and ensure documentation records are accurate, complete and consistent with written procedures.
  • Use computerized systems needed for batch record documentation and document control such as EBR (Electronic Batch Record) and SAP.
Expertise: Knowledge & Skills
  • Requires good written and verbal communication skills
  • Requires good organization and computer skills.
  • Ability to work within clearly defined SOP's and/or methods.
  • Ability to adhere to quality guidelines.


Qualifications
Expertise: Qualifications - Experience/Training/Education

Required:

  • HS diploma or GED and a minimum of 1-2 years of related experience.
Desired:
  • Bachelor's degree in a scientific discipline is preferred.
  • Experience working in aseptic pharmaceutical manufacturing process is preferred.
  • Familiar with FDA regulations pertaining to pharmaceutical manufacturing is 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 30 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 by Process Control Lead/Supervisor.
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 30 pounds.
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.

A little about us:
One of the world's leading healthcare suppliers.

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