AZ, US
23 hours ago
QA Operations Specialist, 3rd Shift

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.

Position: Specialist, Quality Assurance (QA) OperationsLocation: Phoenix

***** 3rd Shift 10pm-6am, Sunday-Thursday*****

Key Responsibilities

Shop Floor Quality (walkthroughs, real time review/assistance) to cover end to end manufacturing operations, maintenance activities and Quality Control laboratories

Triage manufacturing issues real-time to facilitate in determining initial product and process impact and immediate correctionsProvide guidance in triage of events/incidents/escalationsAssist and participate in deviation triagePerforms routine walkthroughs/observations of the manufacturing and laboratory areas with an emphasis of maintaining and improving upon quality and complianceReal-time process and documentation review (e.g., batch records, logbooks, work orders, etc.)Provide Quality and Compliance support to Manufacturing and Laboratory personnel; provide guidance during GMP eventsIdentification of documentation and process improvementsProvides sound quality guidance to all departments and ensures each decision maintains the Safety, Quality, Identity, Potency, and Purity (SQuIPP) of Bristol Myers Squibb (BMS) productsAdopts and constantly utilizes Quality Risk Management (QRM) principles to make sound quality decisionsEnsures the site meets all regulatory standards and consistently produces GMP compliant productRoutine Acceptable Quality Limit (AQL) visual inspection of unpackaged and packaged product

Documentation/Record Review and Approval

Ensure that Standard Operating Procedures (SOPs), Forms, Drawings, Methods, etc. are acceptable for use and provide sufficient justification for change(s) prior to approvalEnsure that works orders (Maintenance and Metrology) are succinct and provide supporting documentation for the work performedBatch related Incident Management tickets have been resolvedIdentification and management of product quarantinesEnsure that Deviation Assessments have included all information/data/objective evidence as required by governing procedures

Aseptic Observation

Observe critical aseptic processes and ensure that manufacturing is performed following good cleanroom behaviors and following aseptic techniquesProvide real time feedback to manufacturing, QC Microbiology and Maintenance to ensure adherence to approved documentationTriage manufacturing issues real time to facilitate in determining initial product and process impact and immediate correctionsIdentify areas of improvement and reinforce best practices

Batch Review of finished product

•    Reviews batch records and assists in release of finished product from the facility to ensure compliance with approved procedures

Resolution to exceptions to the routine manufacturing process uncovered during Batch ReviewManagement of distribution holds

           

Qualifications & Experience

High school diploma or equivalent requiredRequires 20/20 correctable visionBachelor’s degree preferred4 years of relevant work experience required, preferably in Quality Assurance or Quality ControlAn equivalent combination of education, experience and training may substitute.Basic knowledge of cGMP, Occupational Safety Health Administration (OSHA), United States Pharmacopeia (USP), Code of Federal Regulations (CFR), European Pharmacopeia (EP), etc.Ability to multi-task and be flexibleStrong teamwork skillsAbility to complete routine tasks with moderate direction; consults management for advice on complex issues, confident in making decisions for minor issuesAbility to directly contribute to the team performance and team resultsAbility to follow established procedures and performs work as assignedAbility to follow directions and communicate effectively with peers, team and managementAbility to leverage internal relationships within function to achieve objectivesAble to recognize conflict and notify managementBasic writing skills, able to follow technical reportsProvides QA expertise as a resource to identify gaps, facilitate remedial actions, and ensure issues are resolved in a compliant manner.

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.

#On Site

#BMSBL

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 to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to 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/

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

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