Mgr II Quality Assurance
Location:
Irvine , California
Posted:
February 22, 2017
Reference:
2016-8839
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:

Plans, organizes and manages the activities related of the Quality Assurance group in support of a Pharmaceutical Manufacturing Environment. Manages the development and implementation of related Quality Assurance programs to assure compliance to regulatory requirements, and that pharmaceutical manufacturing processes are carried out in a manner to assure the quality, strength, purity, and identity of the products. The position also requires the incumbent to effectively manage the human and budgetary resources necessary to support the company goals while complying with regulatory requirements.

Responsibilities: Essential Duties
  • Oversees the performance of the Quality Assurance function ("Quality on the Floor") in support of pharmaceutical manufacturing to assure that products and processes meet company and regulatory requirements.
  • Works through a multi-level team to carry out the necessary quality processes in support a pharmaceutical environment to include:
  • Oversees the review and approval of pharmaceutical batch record information to support commercial release of product.
  • Mobilizes QA resources to drive the investigation of excursions in Manufacturing or other related operations which may result in abnormal operation rejections. Resolves the nature of the anomaly, the overall impact, material disposition and corrective actions.
  • Manages Non-Conformances and Corrective Action Preventative Action (CAPA) initiatives related to pharmaceutical manufacturing and product quality.
  • Reviews and approves protocols and reports to support change controls.
  • Provides technical support to R&D for new product development.
  • Reviews environmental and manufacturing data trending reports and recommends corrective actions.
  • Writes, revises, and approves Quality department procedures.
  • Provides technical assistance and direction to the other functional groups.
  • Interfaces with regulatory agencies in conjunction with new drug submissions and during routine audits, field complaint investigations and technical interchanges to present the company viewpoint.
  • May conduct internal audits to determine any deficiencies in the Manufacturing, R&D and Distribution Operations as they relate to current regulations.
  • Ensures the efficient use of resources in order to achieve department quality and operation plan objectives.
  • Supervises Quality Assurance personnel to include routine job assignments, performance reviews, training opportunities, and associate development.
  • Responsible for staffing, training and development of subordinates and the control of financial resources to maintain and improve product quality consistent with department and company operating objectives.
Expertise: Knowledge & Skills
  • Broad knowledge of pharmaceutical manufacturing operations and related quality principles.
  • Thorough knowledge of GMPs, GLPs and pharmaceutical products.
  • Demonstrated working acumen of pharmaceutical quality systems to include non-conformances, CAPA, change control, validation, batch review/release, and/or environmental monitoring.
  • Knowledgeable in GMP audit processes.
  • Working knowledge and/or experience in Aseptic Processing/Terminal Sterilization Pharmaceutical Manufacturing.
  • Working knowledge of all phases of pharmaceutical manufacturing and laboratory operations.
  • Familiarity with requirements for submissions to regulatory agencies.
  • Previous active participation in pharmaceutical Health Authority inspections; preferably FDA.
  • Sufficient human relations skills to effectively staff and manage relevant personnel and functions to assure that company goals and responsibilities are met.
  • Demonstrated ability to work in a cross-functional team environment to address the quality, technical, and business needs of the company.
  • Excellent verbal and written communication skills (English).
  • Ability to make verbal presentations to both small and large groups at a variety of levels both inside and outside of the company.
  • Proficient in the use of both personal and mainframe computers including a wide variety of word processing and spreadsheet software packages.


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

Required:
  • BA/BS degree in related science and 8 or more years of experience in a pharmaceutical or medical device company, preferably within B. Braun.
  • 5-7 years previous quality managerial/leadership experience.
  • Demonstrated experience with pharmaceutical regulatory body interactions and/or inspections
  • Limited domestic and/or international travel may be required
Desired:
  • Management of a large diverse quality team supporting a 24/7 pharmaceutical manufacturing operation.

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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