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Job Description
You're an important part of our future. Hopefully, we"re also a part of your future! At B. Braun, we protect and improve the health of people worldwide. You support this vision, bringing expertise and sharing innovation, efficiency and sustainability as values. That's why we would like to keep developing our company with you. Keeping your future in mind, we're making a joint contribution to health care worldwide, with trust, transparency and appreciation. That"s Sharing Expertise.
Documentation Assistant
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, Thursday, Friday, Monday
Shift: 5X8
Relocation Available: No
Requisition ID: 12044
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
The Documentation Assistant supports the Quality and Manufacturing teams by managing controlled documents, maintaining accurate records, and ensuring compliance with internal procedures and regulatory requirements. This role plays a key part in document control, data management, and audit readiness activities.
Key Responsibilities
Issue and manage controlled documents, including batch records, logbooks, notebooks, datasheets, and visual guides
Review documentation for accuracy, completeness, and compliance; resolve discrepancies as needed
Maintain records within the electronic Document Management System (eDMS)
Update and manage product master data in SAP, including Bills of Materials (BOM) and document cross-references
Coordinate implementation of new and revised batch records, protocols, and documentation updates
Manage record retention and destruction in accordance with company policies and regulatory requirements
Track and monitor documentation compliance requirements
Provide guidance to internal stakeholders on document processes, forms, and requirements
Support internal and external audits, including document preparation and follow-up activities
Qualifications
High school diploma or GED required; Associate's or technical degree preferred
Minimum of 2 years experience in document control, quality, or manufacturing support
Experience with document management systems and/or SAP preferred
Skills & Experience
Strong attention to detail and organizational skills
Working knowledge of document control practices and regulatory requirements
Ability to manage multiple tasks and meet deadlines in a fast-paced environment
Effective communication and collaboration skills
Additional Information
Works under general supervision with moderate independence
Primarily office-based with occasional manufacturing floor exposure
Ability to perform light physical tasks (up to 20 lbs)
Regular and predictable attendance required
Pay Range- $28.00- $33.46/ hour
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.
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