Associate II, QASF in Devens, MA
Bristol-Myers Squibb
Associate II, QASF in Devens, MA
Job Description
Provide Quality on-the-floor oversight to Manufacturing/ QC/ Supply Chain Operations & responding to minor issues or escalating to senior members. Perform and document operational verification per approved procedures. Observe manufacturing operations and identify departures from clean room behaviors and aseptic techniques. Provide quality oversight to maintenance operations and support pre-approved return to service plans. Perform area walkthroughs to identify quality issues and support remediation to ensure the floor and operations are in adherence with cGMP and approved procedures. Review manufacturing or testing records to ensure compliance with approved procedures. Communicate and resolve discrepancies and escalate as required. Identifies improvement opportunities and supports execution of site/team continuous improvement goals and projects. Maintain compliance with assigned learning plan. Support internal and external inspections as required. Contribute to the assessment of discrepancies and initiation of quality events. Participate in cross-department and cross-functional meetings, communicate in professional manner and share data/ knowledge within team. Build relationships within direct team and partner functions. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Ability to understand, follow, and apply approved procedures Possess basic computer skills with knowledge of MS Office Ability to understand problems and propose practical solutions Ability to communicate effectively with cross functional peers and direct management through written and verbal skills Ability to work in a fast-paced team environment with changing priorities. Detail oriented and task focused, with the ability to meet deadlines and prioritize assigned work. Ability to recognize the need for escalation of issues. Self-motivated and willingness to learn Bachelor's degree in STEM field preferred. High school diploma/ Associates degree with equivalent combination of education and work experience may be considered. 0-2 years of relevant cGMP experience. Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing is preferred.
Key Responsibilities
- Provide Quality on-the-floor oversight to Manufacturing/QC/Supply Chain Operations
- Respond to minor issues or escalate to senior members
- Perform and document operational verification per approved procedures
- Observe manufacturing operations and identify departures from clean room behaviors and aseptic techniques
- Provide quality oversight to maintenance operations and support pre-approved return to service plans
- Perform area walkthroughs to identify quality issues and support remediation
- Ensure the floor and operations are in adherence with cGMP and approved procedures
- Review manufacturing or testing records to ensure compliance with approved procedures
- Communicate and resolve discrepancies and escalate as required
- Identify improvement opportunities and support execution of site/team continuous improvement goals and projects
- Maintain compliance with assigned learning plan
- Support internal and external inspections as required
- Contribute to the assessment of discrepancies and initiation of quality events
- Participate in cross-department and cross-functional meetings
- Communicate in a professional manner and share data/knowledge within the team
- Build relationships within direct team and partner functions
Required Qualifications
- Bachelor's degree in STEM field preferred
- High school diploma/Associates degree with equivalent combination of education and work experience may be considered
- -2 years of relevant cGMP experience
Preferred Qualifications
- Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing
Skills Required
- Ability to understand, follow, and apply approved procedures
- Possess basic computer skills with knowledge of MS Office
- Ability to understand problems and propose practical solutions
- Ability to communicate effectively with cross-functional peers and direct management through written and verbal skills
- Ability to work in a fast-paced team environment with changing priorities
- Detail oriented and task focused, with the ability to meet deadlines and prioritize assigned work
- Ability to recognize the need for escalation of issues
- Self-motivated and willingness to learn
Benefits & Perks
- Paid national holidays and optional holidays
- Global Shutdown Days between Christmas and New Year's holiday
- Up to 120 hours of paid vacation
- Up to two (2) paid days to volunteer
- Sick time off
- Summer hours flexibility
Locations
- Devens MA, United States
Salary
Estimated Salary Rangemedium confidence
75,000 - 100,000 USD / yearly
Source: ai estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Ability to understand, follow, and apply approved proceduresintermediate
- Possess basic computer skills with knowledge of MS Officeintermediate
- Ability to understand problems and propose practical solutionsintermediate
- Ability to communicate effectively with cross-functional peers and direct management through written and verbal skillsintermediate
- Ability to work in a fast-paced team environment with changing prioritiesintermediate
- Detail oriented and task focused, with the ability to meet deadlines and prioritize assigned workintermediate
- Ability to recognize the need for escalation of issuesintermediate
- Self-motivated and willingness to learnintermediate
Required Qualifications
- Bachelor's degree in STEM field preferred (experience)
- High school diploma/Associates degree with equivalent combination of education and work experience may be considered (experience)
- -2 years of relevant cGMP experience (experience)
Preferred Qualifications
- Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing (experience)
Responsibilities
- Provide Quality on-the-floor oversight to Manufacturing/QC/Supply Chain Operations
- Respond to minor issues or escalate to senior members
- Perform and document operational verification per approved procedures
- Observe manufacturing operations and identify departures from clean room behaviors and aseptic techniques
- Provide quality oversight to maintenance operations and support pre-approved return to service plans
- Perform area walkthroughs to identify quality issues and support remediation
- Ensure the floor and operations are in adherence with cGMP and approved procedures
- Review manufacturing or testing records to ensure compliance with approved procedures
- Communicate and resolve discrepancies and escalate as required
- Identify improvement opportunities and support execution of site/team continuous improvement goals and projects
- Maintain compliance with assigned learning plan
- Support internal and external inspections as required
- Contribute to the assessment of discrepancies and initiation of quality events
- Participate in cross-department and cross-functional meetings
- Communicate in a professional manner and share data/knowledge within the team
- Build relationships within direct team and partner functions
Benefits
- general: Paid national holidays and optional holidays
- general: Global Shutdown Days between Christmas and New Year's holiday
- general: Up to 120 hours of paid vacation
- general: Up to two (2) paid days to volunteer
- general: Sick time off
- general: Summer hours flexibility
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Associate II, QASF in Devens, MA
Bristol-Myers Squibb
Associate II, QASF in Devens, MA
Job Description
Provide Quality on-the-floor oversight to Manufacturing/ QC/ Supply Chain Operations & responding to minor issues or escalating to senior members. Perform and document operational verification per approved procedures. Observe manufacturing operations and identify departures from clean room behaviors and aseptic techniques. Provide quality oversight to maintenance operations and support pre-approved return to service plans. Perform area walkthroughs to identify quality issues and support remediation to ensure the floor and operations are in adherence with cGMP and approved procedures. Review manufacturing or testing records to ensure compliance with approved procedures. Communicate and resolve discrepancies and escalate as required. Identifies improvement opportunities and supports execution of site/team continuous improvement goals and projects. Maintain compliance with assigned learning plan. Support internal and external inspections as required. Contribute to the assessment of discrepancies and initiation of quality events. Participate in cross-department and cross-functional meetings, communicate in professional manner and share data/ knowledge within team. Build relationships within direct team and partner functions. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Ability to understand, follow, and apply approved procedures Possess basic computer skills with knowledge of MS Office Ability to understand problems and propose practical solutions Ability to communicate effectively with cross functional peers and direct management through written and verbal skills Ability to work in a fast-paced team environment with changing priorities. Detail oriented and task focused, with the ability to meet deadlines and prioritize assigned work. Ability to recognize the need for escalation of issues. Self-motivated and willingness to learn Bachelor's degree in STEM field preferred. High school diploma/ Associates degree with equivalent combination of education and work experience may be considered. 0-2 years of relevant cGMP experience. Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing is preferred.
Key Responsibilities
- Provide Quality on-the-floor oversight to Manufacturing/QC/Supply Chain Operations
- Respond to minor issues or escalate to senior members
- Perform and document operational verification per approved procedures
- Observe manufacturing operations and identify departures from clean room behaviors and aseptic techniques
- Provide quality oversight to maintenance operations and support pre-approved return to service plans
- Perform area walkthroughs to identify quality issues and support remediation
- Ensure the floor and operations are in adherence with cGMP and approved procedures
- Review manufacturing or testing records to ensure compliance with approved procedures
- Communicate and resolve discrepancies and escalate as required
- Identify improvement opportunities and support execution of site/team continuous improvement goals and projects
- Maintain compliance with assigned learning plan
- Support internal and external inspections as required
- Contribute to the assessment of discrepancies and initiation of quality events
- Participate in cross-department and cross-functional meetings
- Communicate in a professional manner and share data/knowledge within the team
- Build relationships within direct team and partner functions
Required Qualifications
- Bachelor's degree in STEM field preferred
- High school diploma/Associates degree with equivalent combination of education and work experience may be considered
- -2 years of relevant cGMP experience
Preferred Qualifications
- Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing
Skills Required
- Ability to understand, follow, and apply approved procedures
- Possess basic computer skills with knowledge of MS Office
- Ability to understand problems and propose practical solutions
- Ability to communicate effectively with cross-functional peers and direct management through written and verbal skills
- Ability to work in a fast-paced team environment with changing priorities
- Detail oriented and task focused, with the ability to meet deadlines and prioritize assigned work
- Ability to recognize the need for escalation of issues
- Self-motivated and willingness to learn
Benefits & Perks
- Paid national holidays and optional holidays
- Global Shutdown Days between Christmas and New Year's holiday
- Up to 120 hours of paid vacation
- Up to two (2) paid days to volunteer
- Sick time off
- Summer hours flexibility
Locations
- Devens MA, United States
Salary
Estimated Salary Rangemedium confidence
75,000 - 100,000 USD / yearly
Source: ai estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Ability to understand, follow, and apply approved proceduresintermediate
- Possess basic computer skills with knowledge of MS Officeintermediate
- Ability to understand problems and propose practical solutionsintermediate
- Ability to communicate effectively with cross-functional peers and direct management through written and verbal skillsintermediate
- Ability to work in a fast-paced team environment with changing prioritiesintermediate
- Detail oriented and task focused, with the ability to meet deadlines and prioritize assigned workintermediate
- Ability to recognize the need for escalation of issuesintermediate
- Self-motivated and willingness to learnintermediate
Required Qualifications
- Bachelor's degree in STEM field preferred (experience)
- High school diploma/Associates degree with equivalent combination of education and work experience may be considered (experience)
- -2 years of relevant cGMP experience (experience)
Preferred Qualifications
- Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing (experience)
Responsibilities
- Provide Quality on-the-floor oversight to Manufacturing/QC/Supply Chain Operations
- Respond to minor issues or escalate to senior members
- Perform and document operational verification per approved procedures
- Observe manufacturing operations and identify departures from clean room behaviors and aseptic techniques
- Provide quality oversight to maintenance operations and support pre-approved return to service plans
- Perform area walkthroughs to identify quality issues and support remediation
- Ensure the floor and operations are in adherence with cGMP and approved procedures
- Review manufacturing or testing records to ensure compliance with approved procedures
- Communicate and resolve discrepancies and escalate as required
- Identify improvement opportunities and support execution of site/team continuous improvement goals and projects
- Maintain compliance with assigned learning plan
- Support internal and external inspections as required
- Contribute to the assessment of discrepancies and initiation of quality events
- Participate in cross-department and cross-functional meetings
- Communicate in a professional manner and share data/knowledge within the team
- Build relationships within direct team and partner functions
Benefits
- general: Paid national holidays and optional holidays
- general: Global Shutdown Days between Christmas and New Year's holiday
- general: Up to 120 hours of paid vacation
- general: Up to two (2) paid days to volunteer
- general: Sick time off
- general: Summer hours flexibility
Tags & Categories
Answer 10 quick questions to check your fit for Associate II, QASF in Devens, MA @ Bristol-Myers Squibb.
10 Questions
~2 Minutes
Instant Score
Related Books and Jobs