Specialist, QA Engineering

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This role is responsible for providing quality oversight on technology transfer into and out of the site, process understanding and enhancement, and other site qualification activities in a fast-paced, highly collaborative manufacturing facility. This team supports the Cell Therapy Development early clinical drug product manufacturing facility, which supplies autologous and allogeneic cell therapies for first-in-human and pivotal clinical trials.

Responsibilities :

• QA lead on technology transfer activities (process):
• Ensure technology transfers on new product introduction and/or new trials and cohorts are compliant with internal standards and/or regulatory requirements, as applicable.
• Maintain knowledge of scientific literature, regulatory guidelines, internal standards/procedures and apply key concepts during project activities/plans.
• Interact and coordinate with other QA functional teams to ensure timely completion of QA related activities.
• Interact and collaborate with cross-functional teams to achieve common goals.
• Provide training to QA colleagues on new product manufacturing process, as applicable to ensure clinical production readiness.
• Must be knowledgeable on change control process.
• Must be knowledgeable on the process and associated methods for the assigned product.
• Support Product/Program Lifecycle Management Activities
• Support change initiatives and implementation of new technologies, process and method improvements, material changes and ensure compliance with internal standards and regulatory requirements.
• Support regulatory filings and amendments, as applicable (i.e. IND, INDa, CTA etc.)
• Participate and drive Quality Risk Management (QRM) initiatives at the site to ensure risk areas are identified and risk control measures are implemented.
• Review media simulation activities to ensure successful execution and documentation.
• Maintain data integrity by ensuring procedures/processes are compliant with internal data integrity standards and procedures.
• Work with Engineering/Facilities/Warehouse/Supply Chain/Manufacturing Operations/Quality Control management to ensure functional activities comply with internal standards and regulatory requirements.
• Ensure procedures are adequate to review and confirm appropriateness of data.
• Create an environment of teamwork, open communication, and a sense of urgency
• Promote a mindset of continuous improvement, problem solving, and prevention
• Drive strong collaboration within the site and across the network
• Build trust and effective relationships with peers and stakeholders
• Drive improvements to remove inefficiencies, improve quality and optimize productivity.
• Develop and author training and other documents to educate and to improve consistency, quality, and efficiency in performing routine activities.

Reporting Relationship:

• Reports to Senior Manager, QA Engineering

Qualifications:

• EDUCATION AND EXPERIENCE (As Applicable)
• Minimum of six years of experience in the pharmaceutical or related industry.
• Equivalent combination of education and experience acceptable.

Knowledge, Skills, and Abilities:

• Must have strong understanding of global cGMP, quality systems (especially change management), and guidance documents.
• Must have knowledge of technology transfer for manufacturing processes.
• Must routinely anticipate, recognize and resolve quality issues with minimal direction from management. Inform management of proposed solutions on complex issues.
• Must be able to get resources and information from established internal contacts; consult with supervisor for decisions outside established processes.
• Must have strong authorship and be able to critically review investigations and reports, interpret results, and generate technical conclusions consistent with quality risk management principles.
• Must be able to fully interpret complex results and situations independently and articulate recommendations for solutions. Recognizes risk and develops contingency plans. Negotiates solutions cross-functionally.
• Must be action-oriented, customer-focused, skilled in decision-making, build relationships, good at problem solving, conflict management, planning and organizing, resource allocation, coaching others, and analytical thinking.
• Work is self-directed.
• Must effectively communicate and interact with management and stakeholders with clarity and accuracy.
• Understands fundamental scientific problems.
• Must have strong quality background.

Working Conditions: (US Only)

• Work is performed in a typical office environment, with standard office equipment available and used. Work is generally performed seated, but may require standing and walking for up to 10% of the time. Lighting and temperature are adequate and there are no abnormal conditions caused by noise, dust, etc.
• This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and…