Bristol Myers Squibb
Sr Specialist, QA Shop Floor
Bristol Myers Squibb, Summit, New Jersey, us, 07902
Working with UsChallenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But 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 rich in diversity. Take your career farther than you thought possible.
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. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there's no better place than here at BMS with our Cell Therapy team.
Shift Available:
Wednesday - Saturday (Every other Wednesday off), Onsite overnight shift, 5 p.m. - 5:30 a.m.Responsibilities:
Tech Writer:
Author and revise GMP documents as needed.Assist in executing change controls where needed.Create tutorials to help end-users train on a variety of activities.Create and maintain documentation projects and timelines.Specialist:
Perform Quality Assurance oversight of manufacturing and site activities.Ensure manufacturing compliance with cGMPs, applicable procedures, and batch records.Perform real time review of manufacturing batch records, logbooks, and ancillary documents.Perform product label reconciliation for Manufacturing Operations.Perform GMP Walk-throughs of manufacturing and site areas.Write and approve deviations.Direct quality initiatives that accomplish continuous improvement and enhance site quality system efficiencies.Knowledge & Skills:
Technical Writing
Proven working experience in writing GMP documents.Ability to deliver high-quality documentation under accelerated timelines.Ability to quickly grasp complex technical concepts and make them easily understandable in text.Advanced ability to work in a collaborative team environment and train others.Ability to adapt to changing priorities and manage multiple assignments while meeting timelines.Good organizational skills and critical thinking skills.Excellent written skills in English.Strong working knowledge of Microsoft Office.Specialist:
Must have advanced knowledge and experience with cGMP, Quality Assurance, and compliance.Requires moderate direction to complete more complex tasks; completes routine tasks with little or no supervision.Confident in making decisions for routine/recurring issues.Routinely recognizes and resolves Quality issues; informs management of proposed solutions.Able to effectively communicate and collaborate with other departments when addressing Quality issues.Able to effectively multi-task.Excellent verbal and written communication skills.Able to critically review investigations, interpret results, generate technical conclusions, and make recommendations consistent with Quality Risk Management principles.Basic Requirements:
Bachelor's Degree preferred. An equivalent combination of education and experience will be considered.Minimum of 3 years in Quality Assurance within a manufacturing GMP facility.1 year of direct experience with writing deviations and reviewing investigations.Working Conditions:
The incumbent will work 40 hours per week, including some weekends and holidays if needed.The incumbent may be sitting at a desk and using a computer for prolonged periods of time, up to 8 hours per day.The incumbent may be entering and/or working in a GMP controlled environment.The incumbent may be in the vicinity of biohazardous materials when entering the controlled environments.BMSCART, #LI-Onsite
If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.#J-18808-Ljbffr
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. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there's no better place than here at BMS with our Cell Therapy team.
Shift Available:
Wednesday - Saturday (Every other Wednesday off), Onsite overnight shift, 5 p.m. - 5:30 a.m.Responsibilities:
Tech Writer:
Author and revise GMP documents as needed.Assist in executing change controls where needed.Create tutorials to help end-users train on a variety of activities.Create and maintain documentation projects and timelines.Specialist:
Perform Quality Assurance oversight of manufacturing and site activities.Ensure manufacturing compliance with cGMPs, applicable procedures, and batch records.Perform real time review of manufacturing batch records, logbooks, and ancillary documents.Perform product label reconciliation for Manufacturing Operations.Perform GMP Walk-throughs of manufacturing and site areas.Write and approve deviations.Direct quality initiatives that accomplish continuous improvement and enhance site quality system efficiencies.Knowledge & Skills:
Technical Writing
Proven working experience in writing GMP documents.Ability to deliver high-quality documentation under accelerated timelines.Ability to quickly grasp complex technical concepts and make them easily understandable in text.Advanced ability to work in a collaborative team environment and train others.Ability to adapt to changing priorities and manage multiple assignments while meeting timelines.Good organizational skills and critical thinking skills.Excellent written skills in English.Strong working knowledge of Microsoft Office.Specialist:
Must have advanced knowledge and experience with cGMP, Quality Assurance, and compliance.Requires moderate direction to complete more complex tasks; completes routine tasks with little or no supervision.Confident in making decisions for routine/recurring issues.Routinely recognizes and resolves Quality issues; informs management of proposed solutions.Able to effectively communicate and collaborate with other departments when addressing Quality issues.Able to effectively multi-task.Excellent verbal and written communication skills.Able to critically review investigations, interpret results, generate technical conclusions, and make recommendations consistent with Quality Risk Management principles.Basic Requirements:
Bachelor's Degree preferred. An equivalent combination of education and experience will be considered.Minimum of 3 years in Quality Assurance within a manufacturing GMP facility.1 year of direct experience with writing deviations and reviewing investigations.Working Conditions:
The incumbent will work 40 hours per week, including some weekends and holidays if needed.The incumbent may be sitting at a desk and using a computer for prolonged periods of time, up to 8 hours per day.The incumbent may be entering and/or working in a GMP controlled environment.The incumbent may be in the vicinity of biohazardous materials when entering the controlled environments.BMSCART, #LI-Onsite
If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.#J-18808-Ljbffr