Job Description Summary
The labeling Quality Specialist is responsible to ensure that all pharmaceutical labeling and packaging materials comply with regulatory requirements, company policies, and current Good Manufacturing Practices (cGMP) and FDA requirements via 21 CFR.
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.
Job Responsibilities:
• Maintain labeling program • Maintain/revise current labeling files utilizing Nice Label software. • Assure label changes follow applicable regulations • Assure labeling modifications are compatible with manufacturing operations • Approve / reject labels according to regulatory requirements • Coordinate labeling implementation with external and internal stakeholders • Approve / reject supplier proofs • Coordinate/ Support Raw Material Specification (RMS) revisions • Support document • Approve / reject RMS revisions as applicable • Coordinate training sessions to present RMS changes • Coordinate the First Article process for labeling material • Coordinate Manufacturing Instruction revisions and training associated with labeling changes • Coordinate barcode creations or changes, as needed • Maintain Art Change Forms and Change Control as necessary
Must understand labeling and packaging FDA requirements via 21 CFR.
Education and Experience:
• Bachelor's Degree required • Five years of experience in a medical manufacturing environment • Knowledge and Skills: • Experience in FDA GMP and ISO requirements • Experience in Nice Label and Adobe InDesign • Understand Documentation systems in a medical manufacturing environment
COMPUTER SKILLS:
• Basic Commercial software, MS-Word, Acrobat Suite OTHER SKILLS:
• Must be a team player • Must have excellent communication skills • Proficiency in English grammar
Physical Demands:
• Sitting and work on computer, moderate work on the production floor, moderate walking.
Work Environment:
• Manufacturing
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.
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
Primary Work Location
USA TX - El Paso - Northwestern Dr.
Additional Locations
Work Shift