Process Control Specialist
Location:
Irvine , California
Posted:
October 24, 2017
Reference:
2017-10962
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 limited supervision, responsible for the review of finished product batch records, including the resolution of minor batch-related issues. Assist with investigations, data and documentation collection to facilitate the timely release of product. Perform review and assessment for criticality of Maintenance Work Order (MWO)/Demand Maintenance (DM) activities on manufacturing floor.
Responsibilities: Essential Duties
  • Perform thorough Electronic Batch Record review for Excel product, resolving and approving logs generated during and after batch production.
  • Review and upload related Controlled Data Sheets to the Electronic Batch Record. Make corrections as necessary.
  • Perform full technical review of E3, Glass, PAB, PIC, and Titan batch records.
  • Obtain and/or record necessary corrections from Production and other functional and support areas as needed.
  • Issue and coordinate Quarantine Material Movement documents, track and report test material shipping and arrival for supplemental testing as needed.
  • Perform assessments to determine the criticality of Process instruments, MWOs/PMs/DMs.
  • Review and approve MWOs/PM/DMs to support manufacturing.
  • Update and maintain a number of spreadsheets and databases related to batch review and release.
  • Assist with discrepancy investigations as needed to expedite product corrections and/or re-inspections to facilitate product release.
  • Assist with the coordination, execution, and documentation of Particulate Matter Inspector certifications. Support certification sample preparation, labeling, and storage.
  • Assist with the coordination, execution, and documentation of Annual Reserve sample inspection. Prepare summary reports as necessary.
  • Assist with the tracking and coordination of periodic instrument calibration in the department. Submit instruments for calibration/service as needed, generate related paperwork and provide investigations/rationale/memorandums to facilitate closure of instrument out-of-tolerance notifications.
  • Review Standard Operating Procedures, Specifications, and Test Procedures for accuracy and correctness. Update/revise as needed.
  • Work independently and effectively with various quality functions to assure conformance to FDA regulatory requirements, and internal processes and policies.
  • Utilize computerized systems needed for product release and control, document control and quality investigation processes.
  • Prioritize tasks in a high-pressure and deadline-driven environment.
  • Assist with various validation activities as needed.
  • Attend Material Review Board and Product Release meetings as needed.
Expertise: Knowledge & Skills
  • Excellent written and verbal communication skills (written reports will be required daily).
  • Excellent analytical and trouble shooting skills.
  • Good organization and computer skills.
  • Advanced and specialized expertise typically developed through a combination of job-related training and considerable on-the-job experience as related to a regulated industry.
  • Ability to complete assignments and facilitate the work activities of others; may coordinate work beyond own area.
  • Ability to analyze and propose process improvements.
  • Ability to work autonomously within established procedures and practices.


Qualifications
Expertise: Qualifications - Experience/Training/Education/Etc...

Required:

  • Bachelor's degree in a related field with 2 to 4 years of related work experience.
Desired:
  • Work experience in a GMP manufacturing environment is preferred.
  • Work experience in aseptic pharmaceutical manufacturing process is preferred.
  • Familiarity with FDA regulations pertaining to pharmaceutical/medical device 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 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:

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 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:
  • Typical office work environment. Occasional and limited time in various warehouse and/or manufacturing areas. Clean room gowning may be required occasionally. The noise level in the work environment is usually moderate; however, when working in other areas, requirements for any PPE shall be determined and posted accordingly.
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.

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A little about us:
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