Associate Specialist, Value Stream Cryo Operations
Bristol-Myers Squibb
Associate Specialist, Value Stream Cryo Operations
Job Description
Handling patient material throughout the material Cryopreservation, storage, distribution, transfer, and disposal. Maintaining sample tracking and chain of custody records in accordance with GMP requirements and written procedures. Ensuring that obsolete or expired samples and materials are destroyed and disposed of according to written procedures. Performing sample queries and periodic storage reports, as required. Assisting management with investigations and deviations related to sample management. Collaborating with other departments to identity and implement process efficiencies. Maintaining metrics for the Value Stream Cryo Operations group. Facilitating cold chain transfers of material, as required. Performs tasks for Cell Therapy products to support product Value Stream outputs according to Current Good Manufacturing Practices (cGMP's) following the current, approved Standard Operating Procedures (SOPs) and Work Instructions (WIs). Maintains timing according to the production schedule to ensure on-time Cryopreservation support. Cryopreserve Patient material daily, store and manage Inventory of material in LN2 storage locations. Supports manual and electronic batch record executions, deviation investigations, and closure of CAPAs. Maintains timing according to the production schedule to ensure on-time logistics. Ensures all documentation is correct and addresses procedural/documentation errors expeditiously and effectively. Work with management to ensure adequately trained personnel are available to perform all Value Stream Cryo Operations activities. Records patient material handling data and information in a clear, concise, format according to proper GDPs. Able to problem solve with minimal supervision. Works in a team based, cross-functional environment to complete tasks required by shift schedule. Other duties may be assigned, as necessary. Available to work OT when business requires. Willing to work staggered day shift hours. 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. Basic mathematical skills. General understanding of cGMPs. Technical writing capability. Proficient in MS Office applications. Inventory control and/or management Background to include an understanding of biology, chemistry, medical or clinical practices is a plus. Bachelor's degree with no prior experience. Or associate/ Medical Technical degree and 1-2 years of Manufacturing or Operations experience. Or High School diploma/GED and 3-4 years of Manufacturing or Operations experience. Experience with cold chain sample storage and transfer. Knowledge of cGMP/FDA regulated industry.
Key Responsibilities
- Handle patient material throughout the material Cryopreservation, storage, distribution, transfer, and disposal
- Maintain sample tracking and chain of custody records in accordance with GMP requirements and written procedures
- Ensure obsolete or expired samples and materials are destroyed and disposed of according to written procedures
- Perform sample queries and periodic storage reports, as required
- Assist management with investigations and deviations related to sample management
- Collaborate with other departments to identify and implement process efficiencies
- Maintain metrics for the Value Stream Cryo Operations group
- Facilitate cold chain transfers of material, as required
- Perform tasks for Cell Therapy products to support product Value Stream outputs according to Current Good Manufacturing Practices (cGMP's) following the current, approved Standard Operating Procedures (SOPs) and Work Instructions (WIs)
- Maintain timing according to the production schedule to ensure on-time Cryopreservation support
- Cryopreserve Patient material daily, store and manage Inventory of material in LN2 storage locations
- Support manual and electronic batch record executions, deviation investigations, and closure of CAPAs
- Maintain timing according to the production schedule to ensure on-time logistics
- Ensure all documentation is correct and address procedural/documentation errors expeditiously and effectively
- Work with management to ensure adequately trained personnel are available to perform all Value Stream Cryo Operations activities
- Record patient material handling data and information in a clear, concise, format according to proper GDPs
- Able to problem solve with minimal supervision
- Work in a team-based, cross-functional environment to complete tasks required by shift schedule
- Perform other duties as assigned, as necessary
Required Qualifications
- Bachelor's degree with no prior experience
- Associate/Medical Technical degree and 1-2 years of Manufacturing or Operations experience
- High School diploma/GED and 3-4 years of Manufacturing or Operations experience
Preferred Qualifications
- Background to include an understanding of biology, chemistry, medical or clinical practices
- Experience with cold chain sample storage and transfer
- Knowledge of cGMP/FDA regulated industry
Skills Required
- Basic mathematical skills
- General understanding of cGMPs
- Technical writing capability
- Proficient in MS Office applications
- Inventory control and/or management
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
Additional Requirements
- Available to work overtime when business requires
- Willing to work staggered day shift hours
Locations
- Summit West NJ, United States
Salary
Estimated Salary Rangemedium confidence
70,000 - 110,000 USD / yearly
Source: ai estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Basic mathematical skillsintermediate
- General understanding of cGMPsintermediate
- Technical writing capabilityintermediate
- Proficient in MS Office applicationsintermediate
- Inventory control and/or managementintermediate
Required Qualifications
- Bachelor's degree with no prior experience (experience)
- Associate/Medical Technical degree and 1-2 years of Manufacturing or Operations experience (experience)
- High School diploma/GED and 3-4 years of Manufacturing or Operations experience (experience)
Preferred Qualifications
- Background to include an understanding of biology, chemistry, medical or clinical practices (experience)
- Experience with cold chain sample storage and transfer (experience)
- Knowledge of cGMP/FDA regulated industry (experience)
Responsibilities
- Handle patient material throughout the material Cryopreservation, storage, distribution, transfer, and disposal
- Maintain sample tracking and chain of custody records in accordance with GMP requirements and written procedures
- Ensure obsolete or expired samples and materials are destroyed and disposed of according to written procedures
- Perform sample queries and periodic storage reports, as required
- Assist management with investigations and deviations related to sample management
- Collaborate with other departments to identify and implement process efficiencies
- Maintain metrics for the Value Stream Cryo Operations group
- Facilitate cold chain transfers of material, as required
- Perform tasks for Cell Therapy products to support product Value Stream outputs according to Current Good Manufacturing Practices (cGMP's) following the current, approved Standard Operating Procedures (SOPs) and Work Instructions (WIs)
- Maintain timing according to the production schedule to ensure on-time Cryopreservation support
- Cryopreserve Patient material daily, store and manage Inventory of material in LN2 storage locations
- Support manual and electronic batch record executions, deviation investigations, and closure of CAPAs
- Maintain timing according to the production schedule to ensure on-time logistics
- Ensure all documentation is correct and address procedural/documentation errors expeditiously and effectively
- Work with management to ensure adequately trained personnel are available to perform all Value Stream Cryo Operations activities
- Record patient material handling data and information in a clear, concise, format according to proper GDPs
- Able to problem solve with minimal supervision
- Work in a team-based, cross-functional environment to complete tasks required by shift schedule
- Perform other duties as assigned, as necessary
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 Specialist, Value Stream Cryo Operations
Bristol-Myers Squibb
Associate Specialist, Value Stream Cryo Operations
Job Description
Handling patient material throughout the material Cryopreservation, storage, distribution, transfer, and disposal. Maintaining sample tracking and chain of custody records in accordance with GMP requirements and written procedures. Ensuring that obsolete or expired samples and materials are destroyed and disposed of according to written procedures. Performing sample queries and periodic storage reports, as required. Assisting management with investigations and deviations related to sample management. Collaborating with other departments to identity and implement process efficiencies. Maintaining metrics for the Value Stream Cryo Operations group. Facilitating cold chain transfers of material, as required. Performs tasks for Cell Therapy products to support product Value Stream outputs according to Current Good Manufacturing Practices (cGMP's) following the current, approved Standard Operating Procedures (SOPs) and Work Instructions (WIs). Maintains timing according to the production schedule to ensure on-time Cryopreservation support. Cryopreserve Patient material daily, store and manage Inventory of material in LN2 storage locations. Supports manual and electronic batch record executions, deviation investigations, and closure of CAPAs. Maintains timing according to the production schedule to ensure on-time logistics. Ensures all documentation is correct and addresses procedural/documentation errors expeditiously and effectively. Work with management to ensure adequately trained personnel are available to perform all Value Stream Cryo Operations activities. Records patient material handling data and information in a clear, concise, format according to proper GDPs. Able to problem solve with minimal supervision. Works in a team based, cross-functional environment to complete tasks required by shift schedule. Other duties may be assigned, as necessary. Available to work OT when business requires. Willing to work staggered day shift hours. 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. Basic mathematical skills. General understanding of cGMPs. Technical writing capability. Proficient in MS Office applications. Inventory control and/or management Background to include an understanding of biology, chemistry, medical or clinical practices is a plus. Bachelor's degree with no prior experience. Or associate/ Medical Technical degree and 1-2 years of Manufacturing or Operations experience. Or High School diploma/GED and 3-4 years of Manufacturing or Operations experience. Experience with cold chain sample storage and transfer. Knowledge of cGMP/FDA regulated industry.
Key Responsibilities
- Handle patient material throughout the material Cryopreservation, storage, distribution, transfer, and disposal
- Maintain sample tracking and chain of custody records in accordance with GMP requirements and written procedures
- Ensure obsolete or expired samples and materials are destroyed and disposed of according to written procedures
- Perform sample queries and periodic storage reports, as required
- Assist management with investigations and deviations related to sample management
- Collaborate with other departments to identify and implement process efficiencies
- Maintain metrics for the Value Stream Cryo Operations group
- Facilitate cold chain transfers of material, as required
- Perform tasks for Cell Therapy products to support product Value Stream outputs according to Current Good Manufacturing Practices (cGMP's) following the current, approved Standard Operating Procedures (SOPs) and Work Instructions (WIs)
- Maintain timing according to the production schedule to ensure on-time Cryopreservation support
- Cryopreserve Patient material daily, store and manage Inventory of material in LN2 storage locations
- Support manual and electronic batch record executions, deviation investigations, and closure of CAPAs
- Maintain timing according to the production schedule to ensure on-time logistics
- Ensure all documentation is correct and address procedural/documentation errors expeditiously and effectively
- Work with management to ensure adequately trained personnel are available to perform all Value Stream Cryo Operations activities
- Record patient material handling data and information in a clear, concise, format according to proper GDPs
- Able to problem solve with minimal supervision
- Work in a team-based, cross-functional environment to complete tasks required by shift schedule
- Perform other duties as assigned, as necessary
Required Qualifications
- Bachelor's degree with no prior experience
- Associate/Medical Technical degree and 1-2 years of Manufacturing or Operations experience
- High School diploma/GED and 3-4 years of Manufacturing or Operations experience
Preferred Qualifications
- Background to include an understanding of biology, chemistry, medical or clinical practices
- Experience with cold chain sample storage and transfer
- Knowledge of cGMP/FDA regulated industry
Skills Required
- Basic mathematical skills
- General understanding of cGMPs
- Technical writing capability
- Proficient in MS Office applications
- Inventory control and/or management
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
Additional Requirements
- Available to work overtime when business requires
- Willing to work staggered day shift hours
Locations
- Summit West NJ, United States
Salary
Estimated Salary Rangemedium confidence
70,000 - 110,000 USD / yearly
Source: ai estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Basic mathematical skillsintermediate
- General understanding of cGMPsintermediate
- Technical writing capabilityintermediate
- Proficient in MS Office applicationsintermediate
- Inventory control and/or managementintermediate
Required Qualifications
- Bachelor's degree with no prior experience (experience)
- Associate/Medical Technical degree and 1-2 years of Manufacturing or Operations experience (experience)
- High School diploma/GED and 3-4 years of Manufacturing or Operations experience (experience)
Preferred Qualifications
- Background to include an understanding of biology, chemistry, medical or clinical practices (experience)
- Experience with cold chain sample storage and transfer (experience)
- Knowledge of cGMP/FDA regulated industry (experience)
Responsibilities
- Handle patient material throughout the material Cryopreservation, storage, distribution, transfer, and disposal
- Maintain sample tracking and chain of custody records in accordance with GMP requirements and written procedures
- Ensure obsolete or expired samples and materials are destroyed and disposed of according to written procedures
- Perform sample queries and periodic storage reports, as required
- Assist management with investigations and deviations related to sample management
- Collaborate with other departments to identify and implement process efficiencies
- Maintain metrics for the Value Stream Cryo Operations group
- Facilitate cold chain transfers of material, as required
- Perform tasks for Cell Therapy products to support product Value Stream outputs according to Current Good Manufacturing Practices (cGMP's) following the current, approved Standard Operating Procedures (SOPs) and Work Instructions (WIs)
- Maintain timing according to the production schedule to ensure on-time Cryopreservation support
- Cryopreserve Patient material daily, store and manage Inventory of material in LN2 storage locations
- Support manual and electronic batch record executions, deviation investigations, and closure of CAPAs
- Maintain timing according to the production schedule to ensure on-time logistics
- Ensure all documentation is correct and address procedural/documentation errors expeditiously and effectively
- Work with management to ensure adequately trained personnel are available to perform all Value Stream Cryo Operations activities
- Record patient material handling data and information in a clear, concise, format according to proper GDPs
- Able to problem solve with minimal supervision
- Work in a team-based, cross-functional environment to complete tasks required by shift schedule
- Perform other duties as assigned, as necessary
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 Specialist, Value Stream Cryo Operations @ Bristol-Myers Squibb.
10 Questions
~2 Minutes
Instant Score
Related Books and Jobs