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Specialist, QA

Bristol-Myers Squibb

This is a Full-time position in Phoenix, AZ posted May 2, 2021.

At Bristol Myers Squibb, we are inspired by a single vision transforming patients lives through oncology, hematology, immunology and cardiovascular disease and one of the most diverse and promising pipelines in the industry each of our passionate colleagues contribute to innovations that drive meaningful change.

We bring a human touch to every treatment we pioneer.

Join us and make a difference.

Purpose and Scope of Position The Specialist, QA is responsible for reviewing GMP documentation, and ensuring that commercial products and materials meet required quality characteristics.

The Specialist, QA works within the QA team and alongside other departments to establish and maintain quality assurance systems necessary for ensuring operations are in compliance with current Good Manufacturing Practices, and to ensure the quality characteristics of components, in-process and finished products are met.

Required Competencies:Knowledge, Skills, and Abilities
– Basic knowledge of cGMP, OSHA, USP and EP
– Ability to multi-task and be flexible
– Strong teamwork skills
– Ability to complete routine tasks with moderate direction; consults supervisor for advice on complex issues, confident in making decisions for minor issues
– Ability to directly contribute to the team performance and team results
– Ability to follow established procedures and performs work as assigned
– Ability to follow directions and communicate effectively with peers, team and supervisor
– Ability to leverage internal relationships within function to achieve objectives with guidance
– Able to recognize conflict and notify management
– Basic writing skills, able to follow technical reports Duties and Responsibilities:
– Provides sound quality guidance to all groups and ensures each decision maintains the Safety, Quality, Identity, Potency, and Purity (SQuIPP) of Celgene products and components
– Adopts and constantly utilizes Quality Risk Management principles to make sound quality decisions
– Ensures the site meets all regulatory standards and consistently produces GMP compliant product Customer Service:
– Provides efficient and effective customer support to the other departments at the site
– Works with Plant Operations to ensure compliance with and understanding of cGMPs, SOPs,and policies
– Supports other departments by reviewing and approving change controls, document change controls, investigations, CAPAs, work orders, Metrology documents, and protocols in a timely manner
– Performs Product Quality Complaint (PQC) investigations
– Performs routine visual inspections of product (required for every lot produced)
– Reviews and approves materials for use in commercial production
– Reviews batch records and assists in release of finished product from the facility
– Provides QA expertise as a resource to identify gaps, facilitate remedial actions, and ensure issues are resolved in a compliant manner
– Serves as the chief QA point of contact for any assigned projects/initiatives QA Knowledge and Skills:
– Possesses proficiency in reviewing and approving deviations, change controls, work orders, protocols, reports, batch records, and other GMP documents
– Possesses a strong, detailed knowledge of site’s manufacturing processes and procedures
– Proposes solutions for issues and works with management to resolve
– Actively contributes towards team goals with guidance
– Performs all other tasks as assigned Education and Experience:
– High school diploma or equivalent required
– Bachelors degree preferred
– 4 years of relevant work experience required, preferably in quality assurance/quality control
– An equivalent combination of education, experience and training may substitute Working Conditions:
– Work is generally performed seated, but may require standing and walking for up to 20% of the time
– Work requires satisfactory completion of an eye examination to demonstrate 20/20 correctable vision
– Work requires satisfactory completion of a product inspection qualification
– Work occasionally requires uniform/PPE to work in a manufacturing, warehouse, or laboratory environment Around the world, we are passionate about making an impact on the lives of patients with serious diseases.

Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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.

Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles.

Applicants can request an approval of accommodation prior to accepting a job offer.

If you require reasonable accommodation in completing this application, or any part of the recruitment process direct your inquiries to .

Visit to access our complete Equal Employment Opportunity statement.