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Position: Manager, Senior Quality Assurance Scientist

Location: Manatí PR

Key Responsibilities

1.Supports the site inspection readiness state by: (a) conducting routine walkthroughs through operational areas, (b) observing practices vs procedures, (c) interacting with operational personnel, (d) examining selected batch and non-batch GMP documentation, partnering with Operations to ensure that GMP procedures are consistently followed.

2. Takes QA decisions by applying risk assessment/risk management principles to planned and unplanned events/ issues during operations, using quality/ compliance knowledge and experience, using data, ensuring compliance to GMPs, BMS policies and guidelines.

3. Supports deviation resolution by providing timely inputs and coaching to deviation (functional area) owners. In addition, reviews and approves Deviation Reports from QA standpoint, considering the nature (i.e., severity) of the deviation, frequency and how it was detected, as well as compliance elements (e.g., if the deviation constitutes a departure from a validated state or regulatory filing).

4. For personnel assigned to Inspection/ Packaging: conduct sampling, inspection, and/or evaluation of samples as per finished product specifications & procedures.

5. Reviews and approves procedures or other types of GMP documents (e.g., reports, specifications, drawings, Annual Product Quality Review, special protocols). The review must ensure that the documents are aligned to corporate standards, that families of procedures (of a related topic) are well connected (e.g., for Change Control, Calibrations, product Inspection).

6. Supports activities related to maintenance and calibration of equipment.

7. Ensures there is appropriate monitoring of storage conditions for quarantine materials and products.

8. While reviewing GMP documents, ensures the adequacy and quality of outputs from processes, ensures they are feasible and aligned to cGMP/compliance expectations while being practical, driving for

9. Reviews and approves Manufacturing Batch Records (from all steps), supporting QA Product Disposition process.

10. Conducts basic data analysis, as needed to support deviation/investigations/change management/ technical evaluations, and/or other needs.

11. Reviews and approves Corrective and Preventive actions (CAPA’s) deliverables, ensuring they are appropriately to the deviation root cause(s) and deviation (i.e., the problem statement).

12. Provides key inputs and challenges proposed changes (for improvement, related to CAPAs, etc.) in partnership with the proponents, balancing the need to ensure quality/ compliance while adopting lean/ simplification principles. This may be in support of site projects, or other actions that are managed through the Change Control process and/or procedural change process.

13. Provides assistance to operational areas when a new significant (GMP practice) change is being implemented, helping coach personnel on the GMP principles behind the change.

14. For Quality-owned deviations, leads the Deviation Assessment and conducts and/or support investigations, as needed. This includes generating Investigation Reports, following industry-standard methodologies, Technical Writing, ensuring the investigation is standalone, having, and appropriate breadth & depth.

15. Actively participates in the deviation investigation process, providing inputs, ensuring there is a systematic approach, using facts, data, technical inputs, quality/compliance considerations. Supports development of Impact Assessments and rationale for further processing.

16. Prepares presentations/ materials to reinforce training of GMP topics and/or learnings from events.

17. Delivers periodic Quality Talks, in partnership with Operations management, to communicate to Shop Floor what has been the outcome of key initiatives, deviations, investigations, changes, or emerging industry trends.

18. Supports site initiatives/projects, in addition to the product transfer initiatives and other assignments based on business needs.

19. During peaks of qualifications/ validations, supports the review and approval of related documentation.

20. Support Media Fills activities, ensuring that typical and atypical interventions are performed as established.

21. Supports the Annual Product Review process, for example, with inputs and/or analysis of quality events.

22. Supports departmental budget preparation activities, in addition to budget adherence through time.

23. Identifies opportunities for continuous improvements and leads/ support through completion, as needed.

24. Manages audit observations, investigations, change control and CAPAs records in applicable QMS

25. Assists management during internal and regulatory agencies inspections
 

Qualifications & Experience

1. Bachelor’s degree in science (e.g., Chemistry, Biology, Microbiology, Pharmacy), or Engineering with six (6) years of experience in a role exercising GMP responsibilities in a pharmaceutical industry.

2. Three-five years of practical experience in Quality Systems (e.g., Investigations, CAPA, Change Control) in a GMP manufacturing environment.

3. Knowledge of manufacturing operations of Parenteral Products Manufacturing.

4. In depth knowledge of cGMPs, FDA, EU regulations and the ability to interpret and apply them for intended use.

5. Demonstrable Skills needed:

a. Problem Solving.

b. Critical Thinking;

c. Learning Capability;

d. Analytical Thinking;

e. Attention to Details in review of GMP documents (e.g., in Deviation Reports (manual/ electronic), SOPs, CAPAs,

Logbooks, Reports, Batch Records).

6. Individual must be able to identify what matters require to be dealt with sense of urgency; being able to work under fast-paced conditions and able to quickly identify when Subject Matter Experts and/or Senior Management must be involved.

7. Individual should be a self-starter, with interpersonal skills and ability to interact with people at all levels.

8. Fully bilingual (Spanish/English) with excellent communication skills, both written and verbal.

9. Proficient knowledge of computer systems (Microsoft Office, etc.) and applications like Trackwise/Infinity and SAP.

10. The following pre-requirement only applies to current personnel, and candidates applying, to a position assigned in the Inspection and Packaging areas:

a. Approve the sight screening test established within the Quality Assurance or Packaging Standard Operating

Procedure (SOP).

•Able to work irregular hours, rotational shifts, 8 or 12 hrs shifts, weekends, and holidays, as needed.

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.

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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

BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

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

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

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

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

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