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Position:Manager, Quality Assurance Plant Support Specialist

Location:Humacao

1. Oversee shop floor manufacturing activities by being present during manufacturing activities in order to provide SME quality guidance and/or approval to ensure full compliance with cGMP’s and other regulations.

2. Reviews and approves the executed batch records pertaining to the preparation, formulation, granulation, compressing and coating or any additional stage (e.g. inspection) of the final dosage form of all products manufactured in the Humacao site.

3. Identifies improvements in the working area related to documentation design and flow to the process area.

4. Evaluates quality incidents on the shop floor and provide guidance to operations areas to drive thorough investigations.

5. Assures that Site Quality Events (QE) are completed following site procedures and within the time frame provided in site procedure.

6. Evaluates and approves investigations and CAPA’s for returned goods, damaged goods, process deviations and laboratory investigations.

7. Reviews Quality Events Reports performed by operational areas to assure that Root Cause was identified, adequacy of correctives and preventives actions taken and proposed, report redaction and format is adequate, clear and in compliance with BMS procedure.

6. Recommends material or product disposition, if required.

7. Evaluates specification, recommends and submits changes when necessary to the specifications committee.

8. Reviews and approves completed CAPAs.

9. Provides advice and service to all operating departments as to assure compliance with cGMP’s and other regulations. (This includes frequent feedback on performance regarding deviations, rejections, complaints, outstanding commitments, trends, etc.).

10. Conducts and documents GMP and/or SOP’s training as required.

11. Perform site Walkthrough following applicable procedure.

12. Support readiness exercises for regulatory inspections.

13. Assists in the material / Lots disposition when required.

14. Maintains actively communication with other site Quality and Operational areas to keep lot status posts and drive timely resolution of quality issues.

15. Participates actively in coordination with the QA & Compliance Department during Regulatory inspections and / or during internal company audits.

16. Writes, reviews and implements departmental procedures to assure update with current practices or GMP trends.

17. Reviews and provides Quality Approval to operational areas procedures and Manufacturing Master Documents assuring compliance with current practices and/or GMP trends.

18. Maintains management informed (via frequent written reports) of any problem that might affect the quality and/or timely release of materials.

19. Suggests improvements in the working area related to documentation design and flow to the process area

20. Generates Rejection Notices and rejection labels.

21. Escalates to management relevant situations that may impact product disposition and may cause product shortage in the market.

22. Reviews and approves validation/qualification protocols and final reports, such as, but not limited to:

Equipment Qualification

Process Validation

Computer Validation

Method Transfer & Validation

Periodic Reviews

23. Provides quality perspective and approval for change controls.

24. Performs any special duties assigned by the Senior Manager, Quality Assurance.

• Bachelor in Science (Microbiology, Chemistry, and General Sciences), Engineering or Pharmacy.
• Five (5) years of experience in Pharmaceutical Manufacturing Industry with exposure to Quality and Manufacturing field.
• Broad knowledge on Quality Systems such as Change Control, Investigations and CAPA’s.
• Fully Bilingual (Spanish/English).
• Ability to communicate effectively with wide range of personnel, written and verbal.
• Broad knowledge of relevant governmental regulations, cGMPs and guidelines.
• Solid technical writing skills related to investigation reports
• Ability to create / organize cGMP systems procedures based on regulatory / compliance requirements
• Self-motivated, creative and teamwork oriented.
• Good organizing and planning skills.
• Computer skills (Require using computerized systems).
• Able to work under pressure and availability to work at any time needed.
• Available to work rotating shifts, extra hours and on weekend

BMSBL

#LI-Onsite

If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol
Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.

COVID-19 Information
To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.

BMS is dedicated to ensuring that people with disabilities can perform complex functions through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

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