Principal QA Statistician
Location:
Irvine , California
Posted:
September 07, 2016
Reference:
2016-8732
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:

This Quality position supports a pharmaceutical manufacturing environment through the application of various statistical procedures, methods, and tools. The position will interact with production, engineering, quality and other technical personnel in support of pharmaceutical manufacturing problem solving. It is expected that the incumbent will participate in numerous technical teams as well as serve as an internal consultant relative to statistical approaches to problem solving. In addition, analyses of data and generation of reports to support technical decisions will be required. Use of Statistical programming, Statistical Modeling, and Statistical Tools (i.e. SAS programming, MiniTab, Base SAS/STAT, Excel, and ASCII) will be required.

Responsibilities: Essential Duties
  • Collects and analyzes pharmaceutical manufacturing data via appropriate statistical methods.
  • Performs statistical analyses to drive to decisions to address technical problems.
  • Supports various production, engineering, quality, and technical teams in the evaluation of data; looks for variation trends and helps to establish appropriate control, alert, and action limits.
  • Provides support to pharmaceutical product stability by evaluating product degradation trends and confidence limits.
  • Participates in multi-functional teams as a consultant in developing statistical approaches to solved technical problems.
  • Provides training to fellow associates in basic statistical principles. May be required to present data/information to technical peers and company management.
  • Recommends data management and evaluation approaches to aid in continuous
Expertise: Knowledge & Skills
  • 5 years working in medical devices, biotech/pharmaceutical Industry experience
  • Expertise in statistical principles, methods, and procedures and the ability to instruct others in these areas
  • Demonstrated ability to apply statistical tools and models to help solve manufacturing variability issues
  • Knowledge of statistical sampling practices
  • Previous experience in application of statistical models to predict product long term stability
  • Ability to create novel statistical techniques as needed and to demonstrate the mathematical validity of these techniques
  • Ability to read, analyze, and interpret the most complex documents
  • Excellent verbal and written communication skills
  • Ability to make effective and persuasive presentations on complex topics to management
  • Strong analytical and problem solving skills
  • High degree of initiative and self-motivation
  • Demonstrated ability to identify and adapt to shifting priorities and competing demands
  • Strong attention to detail and accuracy
  • Strong time management and prioritization skills for management of multiple projects
  • Ability to work effectively independently and within teams
  • Strong organization skills
  • Organizational savvy, ability to navigate/network within a large organization


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

Required:
  • Bachelor's degree with 7 years' of experience in Manufacturing Operations data analyst role, or Master's degree with 5 years' of experience in Manufacturing Operations data analyst role, or Ph.D. degree with 2 years of experience in Manufacturing Operations data analyst role.
  • Willing to work flexible hours.
  • Ability to travel up to 5%.
Desired:
  • Experience in Health Care Industry Manufacturing strongly 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:
  • 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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One of the world's leading healthcare suppliers.

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