Job Description Summary

The primary function of this position is to support the maintenance of site wide compliance and the Quality Systems; such as: hosting customer audits, performing internal audits, corrective action and preventative actions (CAPA), develop and deliver training and perform root cause investigations with the ability to offer sustainable actions.
The Document Control focus area is responsible for the coordination and management of the BDM, PS Columbus document control system and the implementation of the SAP document structures. Is the subject matter expert for the Columbus BDM, PS document control system and has the local responsibility for the development, implementation, and improvements of the document system as well as maintaining it in compliance with ISO, cGMP, BDM, PS and BDX requirements. Interfaces directly with BDM, PS sites in Franklin Lakes, Pont de Claix, and Cuautitilan, and the BD Corporate Document group on document control matters.
Ensures compliance with BD quality systems, policies, procedures and best practices, and all local, state, federal and BD safety regulations, policies and procedures. Regular, punctual attendance is an essential job function. Ability to read and write and converse in English. Willing and able to uphold BD Values.

Job Description

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. 

JG3

1st shift – Monday-Friday 8:00AM-5:00PM

Responsibilities include but are not limited to:

Audit focus area:

• Provides assistance with hosting customer audits, maintaining minutes, generating reports for customers and tracking actions through completion.

• Effectively represent BD in customer facing role during audits.

• Conducts internal audits with lead auditor responsibilities.

• Maintain metrics for the quality systems and perform data review which may lead to CAPA.

• Perform root cause investigations for customer complaints including report generation and follow up on actions.

• Support site and Worldwide quality boards (audits, CAPA, and CIR) and Management Reviews in data capture/review and report generation and tracking of actions in a timely manner. Utilize Trackwise or other tracking systems and be able to perform user training of the system.

• Actively coordinate and follow up on actions to meet due dates.

Document Control focus area:

• Brings a high level of manufacturing process and Quality Systems understanding to the review and approval process and has the authority to reject documentation packages when they do not comply with process or system requirements.

• Is responsible for assuring that document types and formats submitted for approval are compliant with BDM, PS and BDX requirements as well as compliance to required approval routings and has the authority to reject document packages when these requirements are not followed.

• Develops and delivers training for associates in use of documentation system and the Engineering Change Order process and mentors users in the document control process.

• Is responsible for the quality and accuracy of the site Electronic Document System (eDoc) including security for access to the system, creation/maintenance of menus, placement of documents (pdf format) on local server, and application of security to block print capability on designated documents.

• Provides Help Desk support to users of documentation system.  This includes creation and monitoring of incident tickets requiring help desk support from System Administrator in Franklin Lakes, NJ.

• Provides timely review and approval of all site document revisions/creations and associated Engineering Change Orders (ECOs) Is the primary document control approval signature for all document and EDO routings.

• Assists change originators in coordination of document releases.

• Coordinates the site 3-year review program by providing a rolling one year schedule of documentation requiring review, and providing a report to the plant leadership team on departmental and overall compliance to the process.

• Maintains:

• Site document templates in documentation system

• User accounts in documentation system

• Site procedures related to document control and table of content

• Archive area specific to the document control group

• Document legacy systems

• Databases used for document system (i.e. TWI Log and Report Card, Document Distribution, Document Number Assignments, User Security Accounts, etc.)

• Leads conversions and upgrades to documentation systems for site.

• Is responsible for identifying and implementing efficiency improvements to the overall document control process.

Other duties as required to support the needs of the business.

• Audit focus:  Successfully host customer audits, Conduct and lead internal audits, Accurate metric documentation, Represent BD Columbus in WW Quality Systems Functions.

• Document Control focus:  Accurate document system, maintenance of and integrity of eDocs system, Timely reporting of document review compliance.

Supervision:

This position does not supervise any associates at any level

Minimum Education :

Required :  BA/BS Degree: Science, Business, Quality or Manufacturing related field

Minimum Experience :

• 2-3 years of experience with BDM, PS product and production methods, including experience with Quality System’s standards (QSR, GMP and ISO)

• Prior experience in the application of the plant Quality System and SAP preferred.

Knowledge skills:

Proficient :

• Attention to detail

• Understanding of the business and manufacturing process that are supported by documentation system

• Computer skills including knowledge of Windows, Word, Excel, Documentum, SAP and database programs

• Complete understanding of the CD/ECM change management (regulatory) procedures and policies

• Communication skills

• Analytical skills

• Problem solving skills

• Organizational skills

• Interpersonal skills

• Self motivated

• Ability to manage change

• Leadership skills

At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.

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.

BD is committed to providing a robust set of value-based programs and resources that are best-in-class, market-competitive and affordable for all associates and their families.

• Competitive pay

  • Access a portion of your pay before pay day with DailyPay

• Healthcare coverage:No paycheck contributions for eligible associates under a certain salary threshold enrolled in the HSA Basic Medical Plan option, no matter how many dependents you cover.

  • Preventive care covered at 100%.

  • Dental and vision insurance at group rates.

• Paid parental leave up to 6 weeks

• Adoption assistance plan

• 401(k) plan with 75 cents on the dollar matched by BD up to 6% of compensation

• Company paid basic life and AD&D insurance

• Tuition reimbursement

• Discounted home, auto and pet insurance

• Paid holidays and vacation (pro-rated the first year based on actual start date)

All benefits and policies are subject to eligibility and enrollment requirements. Most coverage begins on your first day or the date you become eligible for benefits.

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.

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 Employer. We evaluate applicants without regard to 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, and other legally-protected characteristics.

Required Skills

Optional Skills

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Primary Work Location

USA NE - Columbus (East)

Additional Locations

Work Shift