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Documentation Coordinator/Quality Specialist
Company | BD |
Address | , Woburn, Ma |
Employment type | |
Salary | |
Expires | 2023-07-02 |
Posted at | 1 year ago |
Summary
Document Control is the primary contact of Woburn’s electronic document control management system (EDMS). Supports users to achieve consistent and effective usage of the system. Strives to make continual process improvements while adhering to regulatory requirements. Complete all activities for the product release of manufactured lots in Woburn, MA Control and maintain product documentation in both physical and electronic file systems and provide documentation services to all departments.We are the makers of possible
BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.
We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us.
Essential Duties and Position Responsibilities:
- Complete all lot release oriented transactions in the company ERP system and other designated locations.
- Actively communicate the status of lots through the release process to Operations, Quality Management, and Shipping/Receiving.
- Catalog and retrieve archived files as necessary
- Enforce and demonstrate Good Documentation Practices (GDP) at all times
- Maintain a good attendance per attendance guidelines
- Refer any test laboratory or test sample questions to Quality Engineering or QC Supervisor
- Review Device History Files in accordance with all applicable Lot Release Procedures and policies.
- Review and release raw material, sub-assembly, and finished goods products.
- Maintains test sample logs and expedites all samples for testing to internal and external test laboratories
- Perform other related duties as assigned
- Append and maintain logs as required
- Organize and maintain the facility’s quality records, both physically and electronically
Educational Requirements:
- High school diploma or GED
Qualifications, Knowledge, and Skills Required:
- Associates Degree or equivalent experience in administration
- Must be able to type >60WPM
- Knowledge on all office equipment
- Be able to prioritize and work with limited supervision
- Previous experience in electronic documentation systems is a benefit
- Microsoft Word & Excel experience
- Strong communication and attention-to-detail skills
- 1-2 years’ experience working in a technical manufacturing environment
- Work experience in an ISO 13485 or 9001 environment strongly preferred
- Knowledge of Good Manufacturing Practices and Good Documentation Practices
- Must be a quick learner and self-starter
For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.
Why Join Us?
A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It’s also a place where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day.
You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. You will have the opportunity to help shape the trajectory of BD while leaving a legacy at the same time. And through the organization’s investment in BD University, you will continually level up your tech skills and expertise.
To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you’ll discover a culture in which you can learn, grow and thrive. And find satisfaction in doing your part to make the world a better place.
To learn more about BD visit https://bd.com/careers
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
PDN
Primary Work Location
USA MA - WoburnAdditional Locations
Work Shift
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