B. Braun

QA Compliance Specialist

Job Locations US-CA-Irvine
Requisition ID
2022-19988
Company
B. Braun Medical Inc
# of Openings
1
Category
Quality
Position Type
Regular Full-Time
Shift
Monday - Friday 8:00am - 5:00pm
Site
Irvine, CA

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:

 

The QA Compliance Specialist is responsible for reviewing an validating the data in lab notebooks, data print-out, lab test requests, assessments, reports, investigations, and controlled data sheets, and any electronic data, and audit trail generated by the B Braun QC Micro laboratories. 

 

Responsibilities: Essential Duties

 

  • Participate in the development and directions of company's Quality Compliance System to ensure manufacture of products that meet the necessary quality standrads ensuring the quality system'scontinued compliance with all applicable regulatory requirements.
  • Oversee the company risk management program (Annual Reports); provide risk assessment on product nonconformance and field performance issues. Support the company audit program (internal, suppler, customer, and regulatory) to ensure timely and effective corrections to maintain compliance with FDA cGMPs and Quality System Regulations and ISO standards.
  • Support the company supplier management program (ASL, Supplier Quality Agreements) to ensure accurate and compliant supplier file content.
  • Support the company cGMP knowledge management program with HR and Training Department to ensure cGMP proficiency and competency for each worker category. Interface with Manufacturing, Regulatory Affairs, Research & Development, Engineering and other technical disciplines to represent Compliance in project teams, with the objective to assure that project quality compliance objectives are met.
  • Provide technical recommendation for Management and high level technical personnel regarding product cGMP compliance for projects and/or strategic activities. Provide / formulate recommendations for product disposition or other actions related to product nonconformance and field performance issues.
  • Responsible for performing/supporting quality investigations in a timely and thorough manner per applicable investigation procedures. Development, implementation and establish dashboards, accountability boards and metrics to measure quality function performance.
  • Work in the Quality Assurance Oversight team in the Micro labs and perform document technical review.
  • Review and approve data per laboratory notebook and LIMS documentationTechnical review of test execution including all preparations, instrument setup, and data/result generation.
  • Electronic review of Micro testing software.
  • Track review requirements for the released of finished products, Stability and raw materials lots.
  • Participate on cross-functional teams to assist with the closure of chemistry related investigations. Provide technical and compliance input for ensuring robust and complete Micro lab investigations.
  • Review Micro equipment Specifications and Qualification reports.
  • Review and draft investigations and risk-assessments in support of  Microbiology  quality compliance.
  • Provide Assessments for Micro lab related change controls. Review and approve Micro lab related documents, reports, methods and assessments.
  • Compile, review and interpret statistical data and information and present metrics.
  • Benchmark and apply industry best practices .
  • Review, compare and update current documentation of processes and equipment functionality/design to comply with FDA’s Code of Federal Regulations 21 CFR Parts 210 and 211.
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

  • Requires full working knowledge of relevant business practices and procedures in professional field. Uses standard theories, principles and concepts and integrates them to propose a course of action.
  • Work under minimal supervision. Relies on experience and judgement to plan and accomplish assigned goals. May periodically assist in orienting, training , assigning and checking the work of lower level employees. Referring only complex problems and issues
  • Judgement is required in resolving complex problems based on experience.
  • Contacts are primarily with department supervisors, leads, subordinates, and peers. Occasional contact with external contractors/vendors.

Preferred Requirements:

  • Knowledge of SAP, LIMS, LabX.
  • Knowledge of laboratory systems and investigation/deviations.
  • Good working Knowledge of Aseptic and Micro testing techniques.

Qualifications

Expertise: Qualifications -Education/Experience/Training/Etc

 

Required:

  • Bachelor's degree required or equivalent combination of education and experience.
  • 06-08 years related experience required.
  • Applicable industry/professional certification required.
  • Regular and predictable attendance
  • Occasional business travel required

 

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.

 

 

 

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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:Reaching upward and downward, Push/pull
  • Frequently:Stand, Sit
  • Constantly:N/A

Activities:

  • Occasionally:Handling, Push/pull, Reaching upward and downward
  • Frequently:Sitting , Standing, Talking - ordinary, loud/quick, Walking
  • Constantly:N/A

Environmental Conditions:

  • Occasionally:Proximity to moving parts
  • 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:Low
  • Occasionally:Warehouse environment, Lab environment
  • Frequently:Office environment, Production/manufacturing 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

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