Senior Specialist, QA Shop Floor

Celgene • Summit, NJ

221d • Hybrid

About The Position

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. 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. At Bristol Myers Squibb, we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure.

Requirements

• Bachelor's degree in STEM field preferred.
• High school diploma/associate's degree with equivalent combination of education and work experience may be considered.
• A minimum 4 years of relevant experience within Quality Assurance within a manufacturing GMP facility.
• A minimum of 2 years hands-on experience in QMS.
• A minimum of 2 years of experience with risk assessments.
• 1 year of deviation experience.
• Strong project management experience.

Nice To Haves

• Demonstrated experience with quality management systems.
• Demonstrated experience with electronic system and databases such as Manufacturing Execution systems (MES), Enterprise Resource Planning (ERP).
• Ability to research, understand, interpret and apply internal policies and regulatory guidelines.
• Proficient computer skills with knowledge of digital tools such as MS Office, etc. and ability to learn and work with new software applications.
• Ability to interpret data & results, understand complex problems with multiple variables, and articulate practical solutions.
• Excellent written and verbal skills and ability to present technical data effectively based on target audience.
• Ability to work in a fast-paced team environment and lead peers through changing priorities.
• Detail oriented and task focused with ability to meet deadlines and support work prioritization.
• Ability to negotiate and influence to craft mutually beneficial solutions.
• Ability to motivate and foster a positive team environment.
• Exhibit strong decision-making ability and think creatively while maintaining compliance and quality.
• Pioneering mindset and ability to create innovative solutions.

Responsibilities

• Provide Quality on-the-floor oversight to Manufacturing/QC/Warehouse/Packout operations.
• Identify departures from approved procedures & responding to complex issues independently and escalating critical issues to management.
• May perform and document operational verification per approved procedures.
• Develops, reviews and/or approves temporary and non-routine procedure for event response.
• Observe manufacturing operations and identify departures from clean room behaviors and aseptic techniques.
• Provide quality oversight to non-routine maintenance work where applicable.
• Coordinate and lead area walkthroughs to identify quality issues.
• Negotiate remediations and drive alignment of implementation plans.
• Own shift actions for departmental programs and propose improvements to programs.
• Participate in Gemba walks.
• Review manufacturing or testing records to ensure compliance with approved procedures.
• Communicate and resolve discrepancies independently and escalate as required.
• Author, review, and approve procedural documents.
• Maintain compliance with assigned learning plan.
• Provide guidance and training for QA personnel.
• May own training curriculum and content.
• May present individual topics during audits as needed.
• Independently assess discrepancies for entry into quality system and approve deviations as applicable.
• May serve as quality subject matter expert for risk assessments, change controls, etc.
• Lead meetings and represent function at cross functional meetings.
• Share data/knowledge within and across team.
• Build & maintain strong relationships with partner functions.
• May prioritize and assign tasks for the team.

Benefits

• Competitive benefits, services and programs that provide resources to pursue goals at work and in personal lives.

What This Job Offers

• Job Type: Full-time
• Industry: Merchant Wholesalers, Nondurable Goods
• Education Level: Bachelor's degree