Senior Specialist, Quality Assurance Shop Floor for the Warehouse - Trenton, United States - Bristol-Myers Squibb

Description

Senior Specialist, Quality Assurance Shop Floor for the Warehouse
CAROUSEL_PARAGRAPH

• Summit, New Jersey
• Qlty Assurance Methods
• R1553203
• Full Time
• 02/03/2022

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Job Description
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.


REQUIRED COMPETENCIES:

Knowledge, Skills, and Abilities:

Customer Focus:

• Must be action-oriented and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, resource allocation, coaching others, and analytical thinking.
• Understands continuous improvement and improves efficiency and productivity within the group or project.
• Builds relationships internally within and with cross functional teams.
• Contributes to goals within the work group.

Patient Focus:

• Must have sound knowledge and experience in FDA regulated cGMP Quality Warehousing operations and processes.
• Directs quality initiatives that accomplish continuous improvement and enhance site quality system efficiencies.
• Routinely recognizes and resolves Quality issues; Informs management of proposed solutions. Seeks management guidance on complex issues.
• Able to recognize conflict and notify management with proposed recommendations for resolution.

Passion for the Role:

• Must possess an independent mindset. Work is self-directed.
• Requires moderate direction to complete more complex tasks; completes routine tasks with little or no supervision.
• Confident in making decisions for non-routine issues.
• Develops and revises procedures.
• Intermediate to advanced ability to interpret results and situations and articulate recommendations for resolution.
• Able to prepare written communications and communicate problems to management with clarity and accuracy.
• Able to effectively multi-task.
• Knowledge of US and global cGMP requirements.
• Excellent verbal and written communication skills.

EDUCATION AND EXPERIENCE:

• High School Degree required
• Relevant college or university degree preferred.
• Minimum 5-8 years of relevant Quality Assurance and Quality Control Incoming of Materials work experience, in the pharmaceutical, biotech, or medical device industry.
• Knowledge of GMP regulations relating to Warehousing is required.
• Knowledge of Oracle or SAP is preferred.
• Equivalent combination of education and experience acceptable.

DUTIES AND RESPONSIBILITIES:

• Perform QA shop floor activities, focused on Warehouse Operations.
• Perform GMP Walk-Throughs of warehouse areas.
• Oversee Apheresis and PBMC receiving and Drug Product Shipping for both clinical and commercial lots.
• Assess inventory accuracy.
• Build and maintain relationships with Warehouse Operations, Quality Control, Manufacturing and other departments to effectively accomplish responsibilities, make improvements and resolve issues.
• Ensure compliance with applicable procedures and warehouse requirements.
• Perform real-time review of warehouse records and logbooks.
• Must have strong authorship and ability to critically review investigations, interpret results and generate technical conclusions consistent with Quality risk management principles.
• Must be skilled in planning and organizing, decision-making, and building relationships.
• Uphold and support quality processes, including material disposition, material storage and handling requirements, change controls, product complaints, deviations, investigations, and CAPA management.
• May use electronic QMS to document deviations, electronic DMS to review, revise or approve SOPs, and ERP systems to change lot status or perform other data entry.
• Must be available for weekend and off-shift hours.

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 .

Visitto access our complete Equal Employment Opportunity statement.

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

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