Quality Operations Program Lead (Mon-Fri 6:00am-2:30pm) - B. Braun Medical Inc.
Irvine, CA 92623-9791
About the Job
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 Quality Operations Program Lead is responsible for overseeing and ensuring the quality and compliance of manufacturing processes and related quality programs. This role involves managing quality records, leading investigations, and ensuring timely resolution of quality issues while adhering to FDA regulations and cGMP principles. The ideal candidate will leverage strong judgment, critical thinking, and ownership of responsibilities to maintain compliance and promote continuous improvement within a dynamic environment.
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.Lead multiple Quality Programs, ensuring the timely closure of records and compliance with internal and external quality standards.
- Provide quality oversight on manufacturing processes, ensuring compliance with FDA regulations, cGMP, and data integrity standards.
- Support quality investigations by initiating and resolving discrepancy notifications for nonconformance or quality issues.
- Apply quality principles and pharmaceutical cGMP concepts in day-to-day activities.
- Perform routine and repetitious tasks within narrowly defined parameters, following established procedures and guidelines.
- Use judgment and critical thinking to resolve quality-related problems, escalating as necessary.
- Collaborate with cross-functional teams to ensure seamless quality oversight and resolution of issues.
- Monitor real-time quality impacts, assessing risk and ensuring adherence to GDP (Good Documentation Practices).
- Maintain and manage quality records through systems such as EBR (Electronic Batch Records) and SAP.
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
- 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.•
- Strong knowledge of FDA regulations, cGMP, and GDP standards.
- Ability to assess quality impacts and provide timely solutions to ensure compliance.
- Experience in quality systems, investigations, and discrepancy management.
- Strong sense of ownership, attention to detail, and active listening skills.
- Proven ability to work effectively in a team environment, demonstrating collaboration and accountability.
- Competence in multi-tasking and managing priorities in a fast-paced, dynamic setting.
- Proficiency with computer systems, including EBR, SAP, and electronic quality record-keeping tools.
Preferred Requirements
• Bachelor’s degree in a relevant field such as Quality Management, Life Sciences, or Engineering.
• 3+ years of experience in pharmaceutical or quality operations roles, with a focus on cGMP compliance.
• Demonstrated ability to handle multiple responsibilities and maintain a proactive approach to quality assurance.
• Strong communication and interpersonal skills for effective collaboration with cross-functional teams.
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.
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Target Based Range: $28.51 - $34.21 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
- 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.
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Additional Information: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
Equal Opportunity Employer Veterans/Disabled