B. Braun

Supv III QC Process Control

US-CA-Irvine
Requisition ID
2017-11188
Company
B. Braun Medical Inc
# of Openings
1
Category
Quality
Position Type
Regular Full-Time
Shift
5:30pm- 6:30am
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:

Responsible for supervising QC Process Control Associates responsible for performing physical testing, label control, control and disposition of materials, process verifications, environmental monitoring sampling, quality investigations and resolution, batch record review. Ensures that personnel operate efficiently and effectively while performing routine and non-routine tasks.

Responsibilities: Essential Duties

  • Supervises QC Process Control Associates responsible for performing physical testing, label control, control and disposition of materials, process verifications, environmental monitoring sampling, quality investigations and resolution, batch record review.
  • Schedules and coordinates a wide variety of testing and monitoring activities and performs associated supervisory duties, including annual performance reviews.
  • Performs final review of test data/reports to ensure conformance to the established specifications and other related standard operating procedures.
  • Investigates deviations to determine the impact on the product quality, the cause and corrective actions to preclude further deviations of a similar nature.
  • Responsible for performing/supporting quality investigations in a timely and thorough manner per applicable investigation procedures.
  • Reviews technical reports and other sources of information to ensure that practices are consistent with current industry and regulatory requirements. Disseminates related information and updates procedures to reflect current technology.
  • Prepares protocols and technical reports for validating changes to existing products and processes.
  • Interfaces with a wide variety of disciplines to evaluate applicability of existing methods.
  • Assists with or prepares the annual department budget.
  • Supervises the activities of the QC Process Control group in compliance with cGMP and with established policies and procedures.
  • Responsible for final technical review of completed Production Records prior to release to Quality Assurance.
  • Responsible for recruiting and training Process Control Associates.
  • Responsible for developing and revising specifications, procedures and quality systems to support production.
  • Responsible for identifying and resolving in-process deviations and product non-conformances.
  • Responsible to coordinate investigations of deviations and non-conformances to identify the cause and to ensure that appropriate corrective and preventive action is taken. Prepares written investigative reports and analyses to monitor trends and quality issues.
  • Performs technical, GMP, and other training of Process Control associates.

Expertise: Knowledge & Skills

  • Computer knowledge.
  • Theoretical knowledge of subject matter, CGMP, FDA guidelines, GLP and USP’s.
  • Ability to work effectively in a multi-cultural environment.
  • High energy, people oriented individual with the ability to develop and to motivate subordinates.
  • Good organizational skills with the ability to promote and adapt to changes.
  • Excellent verbal and written communication skills are required.
  • Must be able to operate independently, analyze information, and make quality decisions under pressure.

Qualifications

Expertise: Qualifications - Experience/Training/Education/Etc

Required:

  • BA/BS degree in related science.
  • 1 - 3 years of previous supervisory experience.
  • 4 -5 years Quality Control experience.
  • Familiarity with the methods of statistical process control and experience in the design and implementation of sampling plans.

Desired:

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 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.

 

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 IN2017

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