Supervisor III, QA Lab Oversight - Microbiology

B. Braun Medical Inc - Irvine, CA (30+ days ago)4.0


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:
The Quality Assurance Lab oversight Supervisor’s role is to provide quality oversight over all QC Microbiology Laboratory systems, generated raw and meta data, SOPs, Protocols and reports.

Responsibilities: Essential Duties

Provide all aspects of leadership and supervision of personnel within the department
Effectively recruit, evaluate, motivate, train and communicate to assure superior levels of safety, reliability and quality
Ensure that individual and department performance levels meet or exceed goals and expectations
Assists in complying with regulatory requirements related to product safety and quality
Ensures that proper laboratory procedures are being followed as outlined under FDA, ICH and Standard Methods
Ensures proper quality oversight over raw data and meta data generated, including audit trails, in the QC lab through data review
Ensure lab data meets the industry requirements for data integrity
Ensures timely review of associated lab data to meet business and operations requirements
Ensures quality oversight over laboratory SOPs, methods and procedures. Review and approve documents.
Ensures quality oversight over microbiology protocols and reports. Review and approve documents.
Ensures quality oversight over laboratory investigations, review and approve the investigation reports.
Ensures quality oversight over laboratory SOPs, methods and procedures. Review and approve documents.
Ensures quality oversight over laboratory equipment/software qualification, calibration and validation. Review and approve protocols and reports.
Ensures compliance to current compendial methods/chapters/monographs. Track changes/updates and work with the laboratory to evaluate changes and implement updates as applicable.
Judgement is required in resolving day-to-day problems.

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 required in a related field (Microbiology, Biology or other life science).
5 or more years related professional experience
3 or more years of previous supervisory 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:
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.