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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.

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Position: Specialist, Quality Assurance (QA) Operations

Location: 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 corrections
• Provide guidance in triage of events/incidents/escalations
• Assist and participate in deviation triage
• Performs routine walkthroughs/observations of the manufacturing and laboratory areas with an emphasis of maintaining and improving upon quality and compliance
• Real-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 events
• Identification of documentation and process improvements
• Provides sound quality guidance to all departments and ensures each decision maintains the Safety, Quality, Identity, Potency, and Purity (SQuIPP) of Bristol Myers Squibb (BMS) products
• Adopts and constantly utilizes Quality Risk Management (QRM) principles to make sound quality decisions
• Ensures the site meets all regulatory standards and consistently produces GMP compliant product
• Routine 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 approval
• Ensure that works orders (Maintenance and Metrology) are succinct and provide supporting documentation for the work performed
• Batch related Incident Management tickets have been resolved
• Identification and management of product quarantines
• Ensure 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 techniques
• Provide real time feedback to manufacturing, QC Microbiology and Maintenance to ensure adherence to approved documentation

• Triage manufacturing issues real time to facilitate in determining initial product and process impact and immediate corrections

• Identify 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 Review
• Management of distribution holds

Qualifications & Experience

• High school diploma or equivalent required
• Requires 20/20 correctable vision

• Bachelor’s degree preferred
• 4 years of relevant work experience required, preferably in Quality Assurance or Quality Control
• An 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), et