Manager, QA (QAO Microbiology & Chemistry)

Overview

About B. Braun

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 64,000 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:

This position will be leading a large Quality Assurance team responsible overseeing and reviewing data/test results generated by Chemistry and Microbiology Laboratories at the B.Braun Irvine Manufacturing Facility. The Quality Assurance Manager will be responsible for managing a team of eighteen (18) QC data reviewers in QC Chemistry and QC Microbiology disciplines.

The preferred candidate will possess good working and practical knowledge of both chemical and microbiological analytical testing theories and concepts to support laboratory data review (Raw Material, Finished Products, Method Validations, etc.), lab OOS/OOT investigations, lab equipment qualifications, lab audits and change control assessments. It is preferable for the ideal candidate to have hands-on laboratory experience with as many of the following analytical equipment as possible (Chemistry: HPLC, GC, UV-Vis, ICP-OES, FTIR, Spectrophotometers, AA/ GFAA, KF titrators/ coulometers, pH, Balances, etc., Micro: HIAC, Microscope, Kinetic Chromogenic Endotoxin Testers, etc.) and lab software (Empower, LabX, Labware/ Beckman/ Sapphire LIMS, Lonza, WinKQCL, etc.). Candidate must recognize and distinguish the key concepts of Data Integrity (ALCOA+) and their criticality to data reliability, and must have the ability to quickly make decisions on a course of action to address specific issues affecting data review and QA disposition activities. '

Additionally, the position will require the candidate to regularly provide training, support, and guidance to team members, work closely with cross-functional teams to develop and implement process improvements and address issues that impact data quality and compliance. The job duties also include providing feedback to the team to maintain and improve data review process accuracy and efficiency, implement and enforce QC standards and ensure data integrity. The ideal candidate must possess strong analytical skills, excellent attention to detail, outstanding communication and interpersonal skills, and have a proven track record in managing quality assurance initiatives in a fast-paced environment.

Responsibilities: Essential Duties

• Manages programs and activities within the quality assurance functions of an organization.
• Administers policies and programs ensuring that organizational products and processes meet established quality standards.
• Participates in the development, implementation and administration of an organizational quality management system and monitors progress against strategic quality related goals.
• Manages the work of a team of analysts that collect data identifying potential quality failures, evaluate quality of raw materials or components, in progress goods, processes or operations, and implement and measure the impact of corrective actions.
• Solicits internal and external feedback with the goal of continuously improving processes or products.
• Responsible for personnel actions including hiring, performance management, termination.
• Functions as Management Representative.

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

General:

It shall be the duty of every employee while at work to take reasonable care for safety and health of himself/herself and other persons.

Expertise: Knowledge & Skills

• Requires advanced knowledge of professional field and industry.
• Influences the development of and drives the application of principles, theories, concepts.
• Determines best course of action.
• Manages entry to intermediate level employees of a department or a function with 1 or 2 sections.
• Ensures budgets, schedules, and performance requirements are met.
• Judgement is required in resolving complex problems based on experience.
• Contacts are primarily with department supervisors, leads, subordinates, and peers.
• Frequent contact with external contractors/vendors.

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Target Based Range

104,900 - 131,120

Qualifications

Expertise: Qualifications -Education/Experience/Training/Etc

Required:

• Bachelor's degree required.
• 06-08 years related experience required.
• Regular and predictable attendance

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.

Additional Information

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:Stand
• Frequently:Sit
• Constantly:N/A

Activities:

• Occasionally:Standing
• Frequently:Hearing - ordinary, fine distinction, loud (hearing protection required), Sitting , Talking - ordinary, loud/quick
• Constantly:N/A

Environmental Conditions:

• Occasionally:Other
• Frequently:Proximity to moving parts
• 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:Production/manufacturing environment
• Frequently:Office environment, Lab environment
• Constantly:N/A

What We Offer

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.

Notices

Equal Opportunity Employer Veterans/Disabled