QC Microbiology Lead I

Company: B. Braun Medical Inc.
Location: Irvine
Posted on: September 12, 2020

Job Description:

B. Braun Medical Inc., a leader in infusion therapy and pain management, develops, manufactures, and markets innovative medical products and services to the healthcare industry. Other key product areas include nutrition, pharmacy admixture and compounding, ostomy and wound care, and dialysis. The company is committed to eliminating preventable treatment errors and enhancing patient, clinician and environmental safety. B. Braun Medical is headquartered in Bethlehem, Pa., and is part of the B. Braun Group of Companies in the U.S., which includes B. Braun Interventional Systems, Aesculap ® and CAPS ® .

Globally, the B. Braun Group of Companies employs more than 61,000 employees in 64 countries. Guided by its Sharing Expertise ® philosophy, B. Braun continuously exchanges knowledge with customers, partners and clinicians to address the critical issues of improving care and lowering costs. To learn more about B. Braun Medical, visit www.BBraunUSA.com .

Responsibilities Position Summary:

Coordinate execution of routine microbiology activities and special projects with the QC Technical Service Microbiology Lab Associates and cross-functional groups to ensure efficient and effective operation. Provide technical review, direction, and approval for routine microbiology testing. Execute and lead microbiological validations and testing. Coordinate microbiology support for CAPAs, non-conformances, OOS, customer complaints, internal audits and deviations to ensure adherence to quality objectives and standards. Write protocols and report for microbiology validations/studies with the guidance from the QC Microbiology Supervisor. Manage laboratory supply purchasing and inventory.

Responsibilities: Essential Duties

Responsible for microbiological sample receiving/labeling/preparation/sampling/test/ counting/checking and recording of data analysis on finished products, stability test samples and any other test requisitions as directed.

Supports the department in ensuring laboratory equipment performance, i.e. scheduling and execution of equipment qualification (IQ/OQ/PQ), calibration, maintenance and trouble shooting.

Responsible for the compilation and preparation of test results/reports related to laboratory testing.

Supports the department in ensuring continuous test operation, good performance, maintenance and housekeeping of laboratory equipment and facilities.

Checks on test results for compliance to the methods/specification/procedures, equipment operating instructions and guidelines for the superior.

Supports the superior in the preparation of test methods/specification/procedures and equipment operating instructions.

Participates in process and test methods/specification/procedures and equipment operating instructions.

The job function listed is not exhaustive and shall also include any responsibilities as assigned by the Supervisor from time to time.

Expertise: Knowledge & Skills

Assignments are routine and repetitious in nature. Work performed within narrowly defined parameters. Follows established procedures and guidelines.

Works under general supervision. May periodically assist in orienting, training, assigning & checking the work of other peers.

May require some limited judgement in resolving problems

Contacts are primarily with direct supervisor, peers and subordinates.

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

Required:

High school diploma required, Bachelor's degree in a Science related field preferred.

04-06 years related experience required.

Ability to work non-stand schedule as needed

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.

B. 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

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:

While performing the duties of this job, the employee is expected to:

Light work - Exerting up to 20 lbs of force occasionally, and/or up to 10 pounds of force frequently, and/or a negligible amount of force constantly to move objects.

Lifting, Carrying, Pushing, Pulling and Reaching:

Occasionally: Reaching upward and downward, Push/pull, Sit, Visual Acuity with or without corrective lenses

Frequently: Stand

Constantly: N/A

Activities:

Occasionally: Handling, Hearing - ordinary, fine distinction, loud (hearing protection required), Push/pull, Reaching upward and downward, Seeing - depth perception, color vision, field of vision/peripheral, Sitting , Talking - ordinary, loud/quick, Walking

Frequently: Standing

Constantly: N/A

Environmental Conditions:

Occasionally: Exposure to toxic or caustic chemicals (in most areas)

Frequently: N/A

Constantly: N/A

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.

Noise Intensity: Moderate

Occasionally: Office environment, Production/manufacturing environment

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Keywords: B. Braun Medical Inc., Irvine , QC Microbiology Lead I, Other , Irvine, California