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Quality Operations Associate II

Company: B. Braun Medical
Location: Irvine
Posted on: May 16, 2022

Job Description:

B. Braun Medical, Inc.Quality Operations Associate IIUS-CA-IrvineJob ID: 2022-20235Type: Regular Full-Time# of Openings: 1Category: QualityIrvine FacilityOverviewAbout 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.ResponsibilitiesPosition Summary: The Quality Operations Associate II under a moderate degree of supervision is responsible for performing daily routine Quality work in the Label Room and Chain of Custody area to provide direct support for all manufacturing activities from Quality stand point. This position supports the Quality Operations by ensuring compliance with the federal regulations for current Good Manufacturing Practices (cGMP) for finished products and raw materials. This position will also be responsible for reviewing data, certificate of compliance and performing materials release as required. Responsibilities: Essential DutiesMonitors manufacturing process verifications to ensure compliance with operating procedures and specifications.Responsible for performing process monitoring, labeling control, reinspection process monitoring and sampling process for Reserved Samples.Provided quality oversight on manufacturing processes to ensure compliance including data integrity.Provides support for quality investigations and resolution of quality issues. Responsible for performing all chain of custody functions such as sample receiving, verification, distributing to the lab, review cofc documentations for any GDP errors, update labware/EBR, sterility sample transfer, temperature recording etc.Provide quality support by initiating/writing discrepancy or nonconformance for any quality issues.Responsible for performing all label room functions such as label issuance/returns, SAP transactions, daily manufacturing floor challenges, process verifications (may require some tasks observance in cleanroom), SSAD login for samples received with defects, PM certification, etc..Responsible for applying quality principles and pharmaceutical cGMP concept in daily work.Perform routine Quality tasks under limited or no oversight.Responsible for performing all chain of custody functions such as sample receiving, verification, distributing to the lab, review cofc documentations for any GDP errors, update labware/EBR, sterility sample transfer, temperature recording etc..Provide quality support by initiating/writing discrepancy or nonconformance for any quality issues.Responsible for performing all label room functions such as label issuance/returns, SAP transactions, daily manufacturing floor challenges, process verifications (may require some tasks observance in cleanroom), SSAD login for samples received with defects, PM certification, etc..Responsible for applying quality principles and pharmaceutical cGMP concept in daily work.Perform routine Quality tasks under limited or no oversight. 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.Assignments are routine and repetitious in nature. Work performed within narrowly defined parameters. Follows established procedures and guidelines.Works under direct supervision and from detailed verbal and/or written instructions. Uses established procedures to accomplish assigned task.May require some limited judgement in resolving problems.Contacts are primarily with direct supervisor, peers and subordinates. Require to have good knowledge about FDA regulations set for cGMP and GDP.Able to work in team environment.Require to have understanding assessing real time Quality Impact.Need to have strong sense of ownership of given responsibility, attention to details, and be a collaborative/active listener.Ability to multi-task and handle multiple priorities in a dynamic environment with changing priorities.Experience with computers, EBR, SAP, and filling of Quality Records.Good Documentation and proficient in writing discrepancy investigations. Must be able to work in controlled/classified environment. Preferred Requirements: Pharmaceutical/Medical device Industry.Quality Operations/Quality Assurance/Quality Control. QualificationsExpertise: Qualifications - Experience/Training/Education/Etc Required:High school diploma required, Bachelor's degree in a Science related field preferred.01 - 02 years related experience required.Applicable industry/professional certification preferred.Ability to work non-stand schedule as neededRegular and predictable on-site attendanceWhile 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: 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: SitFrequently: Reaching upward and downward, Push/pull, StandConstantly: N/AActivities:Occasionally: SittingFrequently: Handling, Reaching upward and downward, Push/pull, Standing, Talking - ordinary, loud/quick, WalkingConstantly: N/AEnvironmental Conditions:Occasionally: N/AFrequently: Proximity to moving partsConstantly: N/AWork 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: ModerateOccasionally: N/AFrequently: N/AConstantly: Production/manufacturing environmentWhat We OfferB. 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.NoticesEqual Opportunity Employer Veterans/DisabledAll 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.PI177359976

Keywords: B. Braun Medical, Irvine , Quality Operations Associate II, Other , Irvine, California

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