Sr QA Specialist - Quality Computer Systems
Location:
Posted:
August 16, 2016
Reference:
2016-8633
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:

Provides guidance, support, and oversight of Quality Computer System Applications.

Responsibilities: Essential Duties
  • Author and implement corporate and local policies and procedures pertaining to Quality Computer System Applications. These applications may include but not limited to SAP (Quality functions), LIMS, Quality Issue Tracking Software, Laboratory Instrument Computer Systems, Data Warehouse.
  • Provides guidance and leadership concerning Quality Computer System evaluation, selection, validation, and maintenance.
  • May provide technical guidance and supervision to Quality Computer Systems at "sister" B. Braun U.S. facilities.
  • Authors and/or reviews procedures and policies pertaining to Quality Computer System operation, validation, system life cycle maintenance, IT policies and operations.
  • Works with Computer System Validation associates to define standards to ensure compliance with FDA requirements for computer system validation and 21 CFR Part 11 compliance.
  • Authors and/or reviews validation documentation for specific computer systems, Quality equipment/process control systems and computer networks, to include validation plans, system requirements, design and validation protocols/reports.
  • Develops reports and query tools for Quality Computer Systems to facilitate business, compliance, and technical decisions.
  • Evaluates and advises on selection and use of Quality Computer Systems interfaces and laboratory equipment data collection devices.
  • Supervises and otherwise manages personnel and contractors involved in Quality Computer System deployment validation, and maintenance.
  • Reviews regulatory rules and guidelines pertaining to Quality Computer Systems and electronic data and determines their impact on B. Braun U.S. operations. Stays current with FDA requirements for these rules.
  • Performs audits of computer system, software and service suppliers.
  • Plans validation activities and staffing requirements for Quality Computer System projects.
  • Trains B. Braun personnel in Quality Computer System use and operation.
  • Interfaces with personnel both within and outside department, external contractors/consultants, customers and government agencies.
  • Decision making capability when hiring of staff under quality, IT and computer systems requirements.
Expertise: Knowledge & Skills
  • Very good working knowledge of Pharmaceutical (21 CFR 210 & 211).
  • Knowledge of Quality Computer System Applications (LIMS, Trackwise, SAP)
  • Must be able to work as both a team leader and team member.
  • Must have the ability to develop Quality Computer System data reports to enable business, compliance and technical decisions.
  • Must be able to develop user requirements for Quality Computer Systems.


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

Required:
  • BS in Computer Science or equivalent
  • 8 years experience in Quality Computer System Deployment, Validation, and/or Support.
  • Hands-on experience in specification development and validation.
  • Excellent computer skills including experience with word processing, statistical and database applications.
  • Experience with cGMPs and FDA guidelines.
  • Limited domestic and/or international travel may be required
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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