Quality Lead I (Sun-Wed 6:00am-6:00pm)

B. Braun US Pharmaceutical Manufacturing LLC

  • Irvine, CA
  • Permanent
  • Full-time
  • 2 days ago
B. Braun Medical, Inc.Company: B. Braun US Pharmaceutical Manufacturing LLC
Job Posting Location: Irvine, California, United States
Functional Area: Quality
Working Model: Onsite
Days of Work: Wednesday, Tuesday, Monday, Sunday
Shift: 3/4 X 12
Relocation Available: No
Requisition ID: 5874B. 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, visitPosition Summary:Quality Lead I will ensure that all the line support activities run smoothly, which includes attending daily production calls to provide continuous quality oversight for resolving any issues which may arise on daily basis, help initiate Incident Reports, QCRV, Nonconformances, and CDS requests. Additionally, support Quality Monitoring Recertification, PIC Touch test Recertification, and review Reinspection Documentations. It is very important to emphasize Good Documentation Practices, GMP, and Data Integrity.Responsibilities: Essential Duties
  • Responsible for performing process monitoring, labeling control, reinspection process monitoring and sampling process for Reserved Samples.
  • Provides quality oversight on manufacturing processes to ensure compliance including data integrity.
  • Provides routine work direction and training to other Quality Operations Associates.
  • Escalates issues to Supervisor as required.
  • Provides support for quality investigations and resolution of quality issues.
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 personsExpertise: Knowledge & Skills
  • Please refer to the Corporate Guidelines or BBMUS Guidelines or job specific authorities where applicable. This list is however not exhaustive and may be amended by the Management from time to time.
  • Requires working knowledge of technical field/area of specialization. Exercises general application of principles, theories and concepts. 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 department supervisors, leads, subordinates, and peers. Occasional contact with external contractors/vendors.
The targeted range for this role takes into account a range of factors that are considered when making compensation and hiring decisions; included but not limited to: skill sets; experience and training; licensure and certifications; and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. Compensation decisions are dependent on the facts and circumstances of each case. The range provided is a reasonable estimate.$29.36 - $35.23#ID#LI#ALExpertise: Qualifications - Experience/Training/Education/EtcRequired:
  • 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
  • Regular and predictable on-site 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 40 pounds.Responsibilities: Other Duties: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.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: Sit
  • Frequently: Reaching upward and downward, Push/pull, Stand
  • Constantly: N/A
Activities:
  • Occasionally: Sitting
  • Frequently: Handling, Hearing - ordinary, fine distinction, loud (hearing protection required), Push/pull, Reaching upward and downward, Seeing - depth perception, color vision, field of vision/peripheral, Standing, Talking - ordinary, loud/quick, Walking
  • Constantly: N/A
Environmental Conditions:
  • Occasionally: N/A
  • 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: Office environment, Lab environment
  • Frequently: N/A
  • Constantly: Production/manufacturing environment
The targeted range for this role takes into account a range of factors that are considered when making compensation and hiring decisions; included but not limited to: skill sets; experience and training; licensure and certifications; and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. Compensation decisions are dependent on the facts and circumstances of each case. The range provided is a reasonable estimate.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 .Through its “Sharing Expertise®” initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services.We are an equal opportunity employer. We evaluate applications without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, pregnancy, genetic information, disability, status as a protected veteran, or any other protected characteristic. Know Your Rights: Workplace Discrimination is Illegal, .All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.PIae65733c8e17-8722-38038221

B. Braun US Pharmaceutical Manufacturing LLC