- Supports general BOC Quality Assurance activities within the department.
- Develops and maintains training matrix aligned with QMS (Quality Management System) requirements.
- Direct responsibility for monitoring of training database.
- Liaise with other functional/departmental managers to intake all vital requirements to ensure accurate application of associate training verification of efficiency.
- Supports new hire/onboarding programs with responsibility for ensuring Quality System training is completed as established.
- Administrator of Learning Management Systems (e.g., C2C), responsible for creation of user profiles, assignment of user roles, creation and assignment of curricula and preparation of training materials related to changes in current practices and/or procedures.
- Leads training requirements for Change Requests implementation
- Work with third party, internal and external collaborators to ensure training compliance, and objectives are being handled appropriately.
- Monitors, measures and reports Quality related metrics
- Analyzes data and prepares reports for Management Review Mtgs, on behalf of the Director, Quality Assurance, BOC.
- Prepares Weekly/Monthly Reports and others as necessary.
- Responsible for uploading, and custody of, related Guardrails documentation.
- Site Records Coordinator with responsibility for maintenance of the records retention area/process.
- Administrator for electronic systems such as Master Control, Trackwise and others for the BOC site.
- Responsible for maintenance of BOC procedures and for the completion of gap assessments related to Corporate/Global documents (e.g., policies, procedures, standards) as applicable under the direction of the Director, Quality Assurance, BOC.
- Ensures the timely implementation and record of changes in methods and procedures needed to correct and prevent identified quality problems.
- Support, participate and coordinate Internal, External, Third Party and/or regulatory agency audit activities and the corresponding audit actions that may result from them.
- Acts as CAPA process coordinator. May perform CAPAs or evaluate CAPA files.
- Ensures all compliance related files (CAPA, FIR, Complaints, etc) are: established, maintained in a timely & organized manner, well documented, and closed properly.
- Assures are trained before performing any task.
- Uses the required clothes, personal and security protective equipment according to the requirements of its operation.
- Aligns with the cGMP's, Quality Standards and established policies and/or procedures.
- Completes other duties assigned by supervisor.
- Must follow and stay in sync with company policies and procedures, as applicable in the role.
- Bachelor's Degree required. BA/BS in Engineering, Sciences, or Business Administration desired.
- 3 years experience required and 5+ years experience preferred as QA Specialist or similar role in a regulated environment.
- Has knowledge of compliance and Quality Systems.
- Must be bilingual (English/ Spanish) and must have good communication skills both oral and written
- Teamwork oriented
- Proficient on MS Office (Excel, Word, Power Point)
- Must be able to interact with different kinds of people in a harmonious manner, being cognizant of basic corporate, plant and department goals.
- Strong organizational skills
- Problem Solving
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Quality System Specialist - Guaynabo, Puerto Rico - BD
Descripción
Description
We are the makers of possible
BD is one of the largest global medical technology companies in the world. Advancing the world of healthTM 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.
Responsibilities:
Requirements
Education and Experience:
Knowledge, Skills, and Abilities:
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.
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.
