Bristol Myers Squibb
Quality Control RawMaterials and Lab Support Specialist
Bristol Myers Squibb, Summit, New Jersey, us, 07902
Quality Control RawMaterials and Lab Support Specialist
Location: Summit, NJ • Duration: 12 Months • Hybrid - 50% Onsite • Standard Hours: M-F Job Description:
This position is responsible for supporting compliance and technical document-related activities in direct support of clinical and commercial CAR T manufacturing operations. Interfaces with cross-functional groups, independently performs tasks such as technical writing/authoring high-quality technical documents in support of incoming material release. Supports quality compliance responsibilities such as deviations, change management, quality events metrics, and continuous improvements projects within the QC department. Responsibilities
Author and revise GMP documents
Author new documents used in GMP test execution, including material specifications, methods, justification of specifications, SOPs, protocols, and reports
Revise existing documents as needed
Manage development of documents through GMP document management systems
Assist in executing change controls
Work with internal teams to understand process and documentation requirements
Produce high-quality documentation that meets applicable standards for intended audience
Write clear, easy-to-understand instructions
Create and maintain documentation projects and timelines
Provide attention to detail in writings and apply critical thinking to new procedures
Able to take direction from group members
Quality and Compliance
Support End to End (E2E) Deviation/Investigations process (Initiation to Closure)
Assist in investigations (OOS, OOT, deviations) using root cause analysis tools
Perform GEMBA walks with stakeholders to understand process steps and identify improvements with SME coordination
Identify effective CAPAs, develop CAPA plans and ensure CAPA effectiveness
Initiate change control documentation and assist other QC groups with change management docs
Support impact assessments as part of change management
Support QC during audits and site inspections for QC compliance inquiries
Support pulling and reporting quality metrics for the department
Education and Experience
Bachelor's degree required; science preferred; advanced degree preferred
At least 4 years of relevant work experience, preferably in a GxP regulated environment
An equivalent combination of education and experience is acceptable
Requirements
Must have pharma/biotech or regulated health industry experience in a GxP environment
Proven experience in writing/authoring GMP documents per GDPs
Ability to deliver high-volume, high-quality documentation with attention to detail
Ability to understand and apply Global Regulatory and cGMP/GDPs requirements
Ability to grasp complex technical concepts and present them clearly in text and pictures
Hands-on experience with Microsoft Office tools
Experience with electronic systems (TrackWise, Veeva, etc.)
Collaborative team player with ability to train others
Adaptable to changing priorities and able to manage multiple assignments with timelines
Strong organizational and critical thinking skills
Effective communication with peers, management, and cross-functional teams
Application Details
This posting is for a contract assignment with ASK Staffing DBA ASK Consulting to provide services to Bristol Myers Squibb
Starting hourly compensation: $25.08 - $29.08/hr; final compensation determined by the employer of record
About ASK Consulting ASK Consulting is a staffing and recruitment solutions provider with extensive industry experience. We offer ACA-compliant health coverage, dental, vision, disability, commuter benefits, a 401(k) plan, and other benefits as part of our employment package. This posting does not constitute an offer of employment. All applicants must be legally authorized to work in the United States. Equal Opportunity Employer ASK Consulting is an equal opportunity employer and does not discriminate based on race, religion, color, sex, national origin, age, sexual orientation, gender identity, disability, veteran status, or any other protected classification. California Applicant Notice We comply with CPRA and data privacy laws. Please review our Privacy Notice and CCPA Addendum. Applicants may request this notice in an alternate format by contacting HR at askconsulting.com. Instructions, disclaimers, and background check language apply where required by law. This posting does not guarantee employment and offers are made at will. Seniority level Mid-Senior level Employment type Contract Job function Production, Manufacturing, and Quality Assurance Industries: Pharmaceutical Manufacturing and Biotechnology Research
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Location: Summit, NJ • Duration: 12 Months • Hybrid - 50% Onsite • Standard Hours: M-F Job Description:
This position is responsible for supporting compliance and technical document-related activities in direct support of clinical and commercial CAR T manufacturing operations. Interfaces with cross-functional groups, independently performs tasks such as technical writing/authoring high-quality technical documents in support of incoming material release. Supports quality compliance responsibilities such as deviations, change management, quality events metrics, and continuous improvements projects within the QC department. Responsibilities
Author and revise GMP documents
Author new documents used in GMP test execution, including material specifications, methods, justification of specifications, SOPs, protocols, and reports
Revise existing documents as needed
Manage development of documents through GMP document management systems
Assist in executing change controls
Work with internal teams to understand process and documentation requirements
Produce high-quality documentation that meets applicable standards for intended audience
Write clear, easy-to-understand instructions
Create and maintain documentation projects and timelines
Provide attention to detail in writings and apply critical thinking to new procedures
Able to take direction from group members
Quality and Compliance
Support End to End (E2E) Deviation/Investigations process (Initiation to Closure)
Assist in investigations (OOS, OOT, deviations) using root cause analysis tools
Perform GEMBA walks with stakeholders to understand process steps and identify improvements with SME coordination
Identify effective CAPAs, develop CAPA plans and ensure CAPA effectiveness
Initiate change control documentation and assist other QC groups with change management docs
Support impact assessments as part of change management
Support QC during audits and site inspections for QC compliance inquiries
Support pulling and reporting quality metrics for the department
Education and Experience
Bachelor's degree required; science preferred; advanced degree preferred
At least 4 years of relevant work experience, preferably in a GxP regulated environment
An equivalent combination of education and experience is acceptable
Requirements
Must have pharma/biotech or regulated health industry experience in a GxP environment
Proven experience in writing/authoring GMP documents per GDPs
Ability to deliver high-volume, high-quality documentation with attention to detail
Ability to understand and apply Global Regulatory and cGMP/GDPs requirements
Ability to grasp complex technical concepts and present them clearly in text and pictures
Hands-on experience with Microsoft Office tools
Experience with electronic systems (TrackWise, Veeva, etc.)
Collaborative team player with ability to train others
Adaptable to changing priorities and able to manage multiple assignments with timelines
Strong organizational and critical thinking skills
Effective communication with peers, management, and cross-functional teams
Application Details
This posting is for a contract assignment with ASK Staffing DBA ASK Consulting to provide services to Bristol Myers Squibb
Starting hourly compensation: $25.08 - $29.08/hr; final compensation determined by the employer of record
About ASK Consulting ASK Consulting is a staffing and recruitment solutions provider with extensive industry experience. We offer ACA-compliant health coverage, dental, vision, disability, commuter benefits, a 401(k) plan, and other benefits as part of our employment package. This posting does not constitute an offer of employment. All applicants must be legally authorized to work in the United States. Equal Opportunity Employer ASK Consulting is an equal opportunity employer and does not discriminate based on race, religion, color, sex, national origin, age, sexual orientation, gender identity, disability, veteran status, or any other protected classification. California Applicant Notice We comply with CPRA and data privacy laws. Please review our Privacy Notice and CCPA Addendum. Applicants may request this notice in an alternate format by contacting HR at askconsulting.com. Instructions, disclaimers, and background check language apply where required by law. This posting does not guarantee employment and offers are made at will. Seniority level Mid-Senior level Employment type Contract Job function Production, Manufacturing, and Quality Assurance Industries: Pharmaceutical Manufacturing and Biotechnology Research
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