Job Details
Manager, Senior Quality Assurance Scientist
Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us
BASIC EDUCATION AND QUALIFICATIONS:
Bachelor Degree in Science (Chemical, Engineering, Biology, Pharmacy or Microbiology) with six (6) years of experience in Quality Assurance responsibilities in a pharmaceutical industry, or Doctoral Degree (PhD) in Pharmacy with valid License in Pharmacy (Good Standing and / or without Restrictions of Puerto Rico Board of Pharmacy).
Knowledge of manufacturing operations of Oral Solid Dosage and Parenteral Products Manufacturing.
Strong knowledge of relevant GMP, FDA, EU regulations and the ability to interpret and apply them for intended use.
Fully bilingual (Spanish/English) communication skills, both written and verbal.
Self-motivated, creative and team work oriented.
Technical and scientific capability to make firm decisions and recommendations.
Excellent interpersonal skills and the ability to interact with people at all levels
Effective communication Skills
Sense of urgency and analytical thinking
Proficient knowledge of computer systems (Microsoft Office etc.) and applications like Trackwise and SAP
Solid ability for analyzing data detecting deviations, inconsistencies and interpret sampling test results
Proficient knowledge of problem solving and root cause analysis methodologies (i.e. Kepner Tregoe)
Willing to work irregular hours, rotative shifts, weekends and holidays when needed
MAJOR DUTIES AND REPSONSIBILITIES:
Interfaces directly with manufacturing and/or support areas operations to ensure that appropriate procedures are in place, through the execution of thorough reviews of procedures against practice.
Leads and participates in the critical review of all documents associated with the manufacturing and/or support areas operations, release, packaging and relevant activities in the operations areas.
Ensures that deviation on documentation dealing with OOS or process parameters outside filing or validation are investigated and resolved by thoroughly reviewing timely corrective actions.
Provides key technical guidance and oversight to manufacturing and/or support areas operations areas (Sterile, Non-Sterile, QC Laboratories, Warehouse, Engineering, Supply Chain, MS&T, IM, among others to assure the appropriate cGMPs are in place through quarterly, monthly, weekly, or daily operations audits, as applicable.
Ensures compliance of all procedures (SOP’s) to avoid potential regulatory and compliance issues; including GDP and electronic systems compliance.
Provides scientific input into investigations management to assure root cause and CAPAs are aligned with the opportunities identified in order to perform a systematic approach.
Supports actively the investigation processes in manufacturing areas (Sterile and Non Sterile) and support areas such as Warehouse, QC laboratories, IT, MS&T, facilities and utilities providing coaching from Quality perspective.
Provides guidance on gaps identified from the review and actively participates to determine potential remediation activities.
Supports risk analysis process when required per procedures.
Evaluates product impact and provide lot disposition recommendation when an investigation is completed as needed.
Manages audit observation, investigations, change control and CAPAs records in applicable QMS on timely manner.
Provides technical guidance and quality assurance support in the transfer of new products and process to maintain quality standards.
Participates in Manufacturing Alignment Teams (MAT) and Project Alignment Teams (PAT), department staff, planning and change control board meetings, as required.
Evaluates documentation compliance, including data GDP compliance and electronic system data compliance, and its overall management requirements for all manufacturing and support areas, including QC laboratories, such as CR’s, SOP’s, BR’s, Forms, Logbooks, BOM’s, WPP’s, qualification and validation Protocols, according with government regulations and BMS Policies.
Provides support to the area QA Leader during the budget preparation activities.
Evaluates department performance indicators and develop the appropriate corrective actions if needed Assists management during internal and regulatory agencies inspections (FDA, DEA, MCA, etc).
Develops sampling plans based on acceptance quality level criteria when additional or special testing is required.
Performs trend analysis to provide recommendations in order to improve the process and /or the product quality.
Supports Media Fill activities in order to assure that typical and atypical interventions are performed as established.
Supports the Annual Product Review elements for Quality events of manufacturing and environmental monitoring.
Evaluates and approve the instrumentation and equipment calibration records and critical area engineering drawings.
Reviews and approves equipment, utilities and facilities qualification and system life cycle documentation.
Reviews and approves all process, product and computer systems validation protocols and reports, change control documentation, redressing / reprocessing / rework operations, investigation reports related to manufacturing process and microbiology laboratory, and Annual Product Quality Review (APQR’s) elements.
Approves or reject procedures impacting drug products, raw material or packaging components.
Verifies compliance with BMS Policies and Guidelines.
Participates as quality representative or liaison in site projects
Performs pre-operational review form approval in the manufacturing and packaging area.
Performs shop floor walk through audits and challenge adherence with area procedures, coaching and Quality Support in alignment to the business unit to optimize compliance and efficacy.
Verifies consistency with other site procedures and/or specifications.
Reviews and approves investigations related to process, products, utilities, microbiology laboratory and calibrations.
Approves Corrective and Preventive actions (CAPA’s).
Approves or reject specifications impacting drug products, raw material or packaging components.
Ensures there are effective systems for the maintenance and calibration of equipment's and approves of calibration requests.
Ensures the designation and monitoring of storage conditions for quarantine materials and products.
Reviews and approves procedures related to process, products, utilities, and laboratories.
Maintains management informed (via frequent written reports) of any problem that might affect the quality and/or timely release of materials
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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