Quality Associate II at B. Braun US Pharmaceutical Manufacturing LLC – Irvine, California
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About This Position
Company: B. Braun US Pharmaceutical Manufacturing LLC
Job Posting Location: Irvine, California, United States
Functional Area: Quality
Working Model: Onsite
Days of Work: Thursday, Wednesday, Tuesday, Monday, Sunday
Shift: 5X8
Relocation Available: No
Requisition ID: 10591
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
Position Summary:
Our Quality Associate II will support raw material quality control by sampling incoming materials, performing routine physical and identification testing, and ensuring all results meet established specifications. Responsibilities include managing the Raw Material retain program, conducting daily instrument calibration and maintenance within a cGMP environment, and maintaining accurate, realtime laboratory documentation to support quality release and audit readiness.
This position reports to Megan Jang, Quality Assurance Mgr III and will be fully onsite Sunday- Thursday, 7 AM to 3:30 PM.
Responsibilities: Essential Duties
Monitors manufacturing process verifications to ensure compliance with operating procedures and specifications. -Provides support for quality investigation which includes initiation and supporting data for the resolution of quality issues.
Provides Quality oversight over the Quality System, including but not limited to the review, reports, data (including Meta data) and records generated to support the manufacturing and distribution of product.
Conducts timely Quality review of associated data, including data utilized to support batch release, to meet business and operations requirements.
Assists in complying with regulatory requirements related to product safety and quality.
Ensures that procedures are being followed as outlined under FDA, ICH, Standard methods and the Quality System requirements.
Reviews records to ensure data meets the industry requirements for data integrity.
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.
Ability to work non-standard schedule as needed
Required:
High school diploma/G.E.D or equivalent required, Associate's or technical degree preferred.
01-02 years related experience required.
Regular and predictable on-site attendance
Compensation: $28.41 - $30.81
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 www.bbraunusa.com.
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, click here.
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.
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Job Location
Job Location
This job is located in the Irvine, California, 92602, United States region.