What are the responsibilities and job description for the Specialist, Quality Assurance Shop Floor - Devens, MA position at VetJobs?
Job Description
ATTENTION MILITARY AFFILIATED JOB SEEKERS - Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers. If you have the required skill set, education requirements, and experience, please click the submit button and follow the next steps. Unless specifically stated otherwise, this role is "On-Site" at the location detailed in the job post.
Challenging. 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. 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. Read more: careers.bms.com/working-with-us.
Working with Us
Challenging. 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. 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.
Position Summary
The Quality Assurance Shop Floor team is responsible for 24x7 Quality collaboration and oversight of site operations, including but not limited to Manufacturing, Quality Control laboratories, and Warehouse Operations.
This position will oversee and partner with operational areas, to ensure compliance with Bristol-Myers Squibb policies, standards, procedures, and Global cGMP.
Shift: Day shift, Panama schedule (12-hour shift patterns with a 2-2-3 work cycle including weekends and holidays)
6 am to 6 pm
Duties/Responsibilities
Provide routine Quality on-the-floor oversight and triage unexpected events with Manufacturing, Quality Labs, and Supply Chain operations.
Able to interpret problems and effectively prepare surrounding communication in a productive manner to management and to the group with clarity, brevity, and accuracy.
Identify departures from approved procedures and respond to issues independently while escalating complex issues to senior members.
Perform and document operational verification within Manufacturing Execution System (MES) per approved procedures.
Observe manufacturing operations and identify departures from procedures, cleanroom behaviors and aseptic techniques.
Provide quality oversight for pre-planned return to service plans.
Perform area walkthroughs to identify quality issues, propose remediations and support implementation plans with area owners.
Identify and propose improvements to programs, procedures, and practices.
Review manufacturing batch records or QC testing records to ensure compliance with approved procedures.
Review and provide feedback on documents such as forms, logbooks, and procedures.
Maintain compliance with assigned learning plan. Provide integration support of newer team members.
Independently approve deviation records within the quality management system consistent with quality risk management principles and in accordance with process knowledge
Review and interpret the technical conclusions of a record/investigation and provide constructive feedback.
Participate in quality and shift meetings.
Build and maintain relationships with core partner functions and seek collaborative solutions.
Share data/knowledge within team by acting as a champion for quality-culture.
Auto req ID
470963BR
Minimum Education Required
High School/GED
Job_Category
Health/Medical other
Qualifications
Additional Qualifications/Responsibilities
Specific Knowledge, Skills, Abilities
Must be action-oriented and proficient in decision-making, building relationships, problem-solving, and analytical thinking.
Ability to understand, follow, and apply internal policies, procedures, and quality principles.
Prior experience with quality processes, including batch record review, material disposition, change control, product complaints, deviations, investigations, and CAPA management.
Ability to assess an unfolding situation, diagnose the problem, and propose practical solutions.
Detail-oriented and task-focused with the ability to meet deadlines and prioritize assigned work.
Ability to work in a fast-paced team environment with changing priorities with limited information and/or time-constraints.
Effectively communicate with cross-functional peers and various levels of management through technical writing and verbal skills.
Active listening skills to understand diverse working perspectives.
Contributes to a positive team environment.
Able to independently make decisions based on data and facts, and recognizes when to escalate
Seeks opportunities for improvement to quality and operational problems.
Ability to work within pharmaceutical cleanroom environments.
Experience with quality management systems for handling of records such as change control, product complaints, deviations, investigations, and CAPA management.
Experience with GxP electronic systems such as Manufacturing Execution Systems (MES) for electronic batch records; Enterprise Resource Planning (ERP) such as SAP; laboratory information management systems; or electronic logbooks/forms.
Proficient with digital tools like Microsoft Power Automate, Smartsheet, Tableau, etc.
Education/Experience/Licenses/Certifications
Bachelor's degree in STEM field. High school diploma or associate’s degree with equivalent combination of education and work experience is considered.
2 years of relevant cGMP experience with 1 year of manufacturing site experience.
Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing.
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.
Compensation Overview
Devens - MA - US: $40.16 - $48.67per hour
The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.
City*
Devens
State*
Massachusetts
Job Code
Pharmaceutical Pharmaceutical
Affiliate Sponsor
Bristol Myers Sqibb BMS
ATTENTION MILITARY AFFILIATED JOB SEEKERS - Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers. If you have the required skill set, education requirements, and experience, please click the submit button and follow the next steps. Unless specifically stated otherwise, this role is "On-Site" at the location detailed in the job post.
Challenging. 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. 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. Read more: careers.bms.com/working-with-us.
Working with Us
Challenging. 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. 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.
Position Summary
The Quality Assurance Shop Floor team is responsible for 24x7 Quality collaboration and oversight of site operations, including but not limited to Manufacturing, Quality Control laboratories, and Warehouse Operations.
This position will oversee and partner with operational areas, to ensure compliance with Bristol-Myers Squibb policies, standards, procedures, and Global cGMP.
Shift: Day shift, Panama schedule (12-hour shift patterns with a 2-2-3 work cycle including weekends and holidays)
6 am to 6 pm
Duties/Responsibilities
Provide routine Quality on-the-floor oversight and triage unexpected events with Manufacturing, Quality Labs, and Supply Chain operations.
Able to interpret problems and effectively prepare surrounding communication in a productive manner to management and to the group with clarity, brevity, and accuracy.
Identify departures from approved procedures and respond to issues independently while escalating complex issues to senior members.
Perform and document operational verification within Manufacturing Execution System (MES) per approved procedures.
Observe manufacturing operations and identify departures from procedures, cleanroom behaviors and aseptic techniques.
Provide quality oversight for pre-planned return to service plans.
Perform area walkthroughs to identify quality issues, propose remediations and support implementation plans with area owners.
Identify and propose improvements to programs, procedures, and practices.
Review manufacturing batch records or QC testing records to ensure compliance with approved procedures.
Review and provide feedback on documents such as forms, logbooks, and procedures.
Maintain compliance with assigned learning plan. Provide integration support of newer team members.
Independently approve deviation records within the quality management system consistent with quality risk management principles and in accordance with process knowledge
Review and interpret the technical conclusions of a record/investigation and provide constructive feedback.
Participate in quality and shift meetings.
Build and maintain relationships with core partner functions and seek collaborative solutions.
Share data/knowledge within team by acting as a champion for quality-culture.
Auto req ID
470963BR
Minimum Education Required
High School/GED
Job_Category
Health/Medical other
Qualifications
Additional Qualifications/Responsibilities
Specific Knowledge, Skills, Abilities
Must be action-oriented and proficient in decision-making, building relationships, problem-solving, and analytical thinking.
Ability to understand, follow, and apply internal policies, procedures, and quality principles.
Prior experience with quality processes, including batch record review, material disposition, change control, product complaints, deviations, investigations, and CAPA management.
Ability to assess an unfolding situation, diagnose the problem, and propose practical solutions.
Detail-oriented and task-focused with the ability to meet deadlines and prioritize assigned work.
Ability to work in a fast-paced team environment with changing priorities with limited information and/or time-constraints.
Effectively communicate with cross-functional peers and various levels of management through technical writing and verbal skills.
Active listening skills to understand diverse working perspectives.
Contributes to a positive team environment.
Able to independently make decisions based on data and facts, and recognizes when to escalate
Seeks opportunities for improvement to quality and operational problems.
Ability to work within pharmaceutical cleanroom environments.
Experience with quality management systems for handling of records such as change control, product complaints, deviations, investigations, and CAPA management.
Experience with GxP electronic systems such as Manufacturing Execution Systems (MES) for electronic batch records; Enterprise Resource Planning (ERP) such as SAP; laboratory information management systems; or electronic logbooks/forms.
Proficient with digital tools like Microsoft Power Automate, Smartsheet, Tableau, etc.
Education/Experience/Licenses/Certifications
Bachelor's degree in STEM field. High school diploma or associate’s degree with equivalent combination of education and work experience is considered.
2 years of relevant cGMP experience with 1 year of manufacturing site experience.
Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing.
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.
Compensation Overview
Devens - MA - US: $40.16 - $48.67per hour
The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.
City*
Devens
State*
Massachusetts
Job Code
Pharmaceutical Pharmaceutical
Affiliate Sponsor
Bristol Myers Sqibb BMS
Salary : $40 - $49