10 days old

Manufacturing Documents Coordinator

Sunnyvale, CA 94086

Perform documentation reviews and material transactions to ensure timely and accurate reviews and submission of device history records along with maintaining an accurate inventory. Identify and make recommendations for new procedural and process improvements. Provide leadership and support in ensuring quality, lowering cost and improving productivity in production.

- Works with SAP and other inventory management system.
- Performs material transactions in SAP and DHR review for release in compliance with standards for good manufacturing practices.
- Monitors and provide updates on DHR review and release priority
- Data entry (Raw materials, IPT spreadsheet)
- Participate in Daily Management in reporting daily metrics
- Archiving of DHRs turned in to QA
- Logs DHR errors and coordinate with production supervisors for the correction
- Ensure batch records are complete and accurate.
- Identify and eliminate sources of inefficiencies.

Education or Experience (in years): 
- 2+ years of related experience
- High School diploma/GED or equivalent experience
- Experience in clean room assembly or Manufacturing in the medical device, pharmaceutical or biotech industry, or equivalent combination of education and experience.
- Experience in FDA audits
Knowledge and skills: 
- Understands GMP and Good Documentation Practice (GDP)
- Ability to clearly and effectively communicate with peers, supervisors, engineers, managers, leads and upper management.  Able to understand any given instructions and batch records written and spoken in English.
- Effective verbal and written communication skills
- Ability to pay close attention to detail
- Basic Computer Skills including Microsoft Excel
- Ability to solve basic math problems
- Able to identify each station of the machinery
- Able to contribute to the development of concepts and techniques
Physical requirements/abilities: 
- Knowledge of SAP ERP system

Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The €œEEO is the Law€ poster is available here.","industry":"Biotechnology


Posted: 2020-05-21 Expires: 2020-06-20

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Manufacturing Documents Coordinator

Sunnyvale, CA 94086

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