QA Operations Specialist - 2nd/3rd Shift

At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In 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.

***Position will be a split shift between 2nd and 3rd shift***

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 management 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 management

• Ability to leverage internal relationships within function to achieve objectives

• Able to recognize conflict and notify management

• Basic writing skills, able to follow technical reports

Duties and Responsibilities

• 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 and materials

• 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

Education and Experience

• High school diploma or equivalent required

• Bachelor’s 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

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, and work orders in a timely manner

• Assist with Product Quality Complaint (PQC) investigation

• Assist with review of validation documentation

• Performs routine visual inspections (required for unpackaged and packaged 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

QA Knowledge and Skills

• Possesses proficiency in reviewing and approving deviations, change controls, work orders, validation documentation, 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

• Performs all other tasks as assigned

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

BMS BL

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.

Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.

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.

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 if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

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