Scientist, QC Microbiology
Bristol-Myers Squibb
Scientist, QC Microbiology
Job Description
Subject matter expert supporting method transfer/verification/ validation and routine testing of in-process, final product, and stability samples. Perform review of testing data (e.g., data packets, final lot file, COA review). Anticipate and perform complex troubleshooting and problem solving independently. Perform data verification, data review and review of GMP documentation for multiple methods (general and complex) and/or products. Own project, CAPA and deviation/ investigation related tasks and/ or continuous improvement efforts. May represent the department in regulatory inspections (internal and external audits). Train and mentor others on multiple QC test methods, processes and procedures. Cross trained on multiple complex microbiology methods and/or multiple products. Author and review/ revise technical documents such as test methods, SOPs, specifications, trend reports and/or sample plans as appropriate. Perform other tasks as required to support the QC laboratories. Bachelor's degree or equivalent required, preferably in Science. Advanced degree preferred. NL: Bachelor's degree (HLO) required 6+ years of relevant microbiological testing or QC experience or equivalent combination of education and experience, preferably in a regulated environment. Demonstrated experience with microbiological techniques. Ability to accurately and completely understand, follow, interpret and apply Global Regulatory and cGMP requirements. Demonstrated technical writing skills. High problem-solving ability/mentality, technically adept and logical. Ability to communicate effectively with peers, department management and cross-functional peers about task status, roadblocks and needs. Ability to work in a fast-paced team environment, meet deadlines, and prioritize work. Advanced knowledge of LIMS, ELN and laboratory data analysis systems preferred. Strong mentoring, coaching, influencing, negotiating and personnel interaction skills.
Key Responsibilities
- Support method transfer/verification/validation and routine testing of in-process, final product, and stability samples
- Perform review of testing data including data packets, final lot file, and COA review
- Anticipate and perform complex troubleshooting and problem solving independently
- Perform data verification, data review and review of GMP documentation for multiple methods and/or products
- Own project, CAPA and deviation/investigation related tasks and/or continuous improvement efforts
- Represent the department in regulatory inspections (internal and external audits)
- Train and mentor others on multiple QC test methods, processes and procedures
- Cross train on multiple complex microbiology methods and/or multiple products
- Author and review/revise technical documents such as test methods, SOPs, specifications, trend reports and/or sample plans
- Perform other tasks as required to support the QC laboratories
Required Qualifications
- Bachelor's degree or equivalent, preferably in Science
- + years of relevant microbiological testing or QC experience or equivalent combination of education and experience
- Demonstrated experience with microbiological techniques
Preferred Qualifications
- Advanced degree
- Experience in a regulated environment
- Advanced knowledge of LIMS, ELN and laboratory data analysis systems
Skills Required
- Ability to accurately and completely understand, follow, interpret and apply Global Regulatory and cGMP requirements
- Demonstrated technical writing skills
- High problem-solving ability/mentality, technically adept and logical
- Ability to communicate effectively with peers, department management and cross-functional peers about task status, roadblocks and needs
- Ability to work in a fast-paced team environment, meet deadlines, and prioritize work
- Strong mentoring, coaching, influencing, negotiating and personnel interaction skills
Locations
- Leiden – NL, United States
Salary
Estimated Salary Rangemedium confidence
60,000 - 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 accurately and completely understand, follow, interpret and apply Global Regulatory and cGMP requirementsintermediate
- Demonstrated technical writing skillsintermediate
- High problem-solving ability/mentality, technically adept and logicalintermediate
- Ability to communicate effectively with peers, department management and cross-functional peers about task status, roadblocks and needsintermediate
- Ability to work in a fast-paced team environment, meet deadlines, and prioritize workintermediate
- Strong mentoring, coaching, influencing, negotiating and personnel interaction skillsintermediate
Required Qualifications
- Bachelor's degree or equivalent, preferably in Science (experience)
- + years of relevant microbiological testing or QC experience or equivalent combination of education and experience (experience)
- Demonstrated experience with microbiological techniques (experience)
Preferred Qualifications
- Advanced degree (experience)
- Experience in a regulated environment (experience)
- Advanced knowledge of LIMS, ELN and laboratory data analysis systems (experience)
Responsibilities
- Support method transfer/verification/validation and routine testing of in-process, final product, and stability samples
- Perform review of testing data including data packets, final lot file, and COA review
- Anticipate and perform complex troubleshooting and problem solving independently
- Perform data verification, data review and review of GMP documentation for multiple methods and/or products
- Own project, CAPA and deviation/investigation related tasks and/or continuous improvement efforts
- Represent the department in regulatory inspections (internal and external audits)
- Train and mentor others on multiple QC test methods, processes and procedures
- Cross train on multiple complex microbiology methods and/or multiple products
- Author and review/revise technical documents such as test methods, SOPs, specifications, trend reports and/or sample plans
- Perform other tasks as required to support the QC laboratories
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Answer 10 quick questions to check your fit for Scientist, QC Microbiology @ Bristol-Myers Squibb.
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Scientist, QC Microbiology
Bristol-Myers Squibb
Scientist, QC Microbiology
Job Description
Subject matter expert supporting method transfer/verification/ validation and routine testing of in-process, final product, and stability samples. Perform review of testing data (e.g., data packets, final lot file, COA review). Anticipate and perform complex troubleshooting and problem solving independently. Perform data verification, data review and review of GMP documentation for multiple methods (general and complex) and/or products. Own project, CAPA and deviation/ investigation related tasks and/ or continuous improvement efforts. May represent the department in regulatory inspections (internal and external audits). Train and mentor others on multiple QC test methods, processes and procedures. Cross trained on multiple complex microbiology methods and/or multiple products. Author and review/ revise technical documents such as test methods, SOPs, specifications, trend reports and/or sample plans as appropriate. Perform other tasks as required to support the QC laboratories. Bachelor's degree or equivalent required, preferably in Science. Advanced degree preferred. NL: Bachelor's degree (HLO) required 6+ years of relevant microbiological testing or QC experience or equivalent combination of education and experience, preferably in a regulated environment. Demonstrated experience with microbiological techniques. Ability to accurately and completely understand, follow, interpret and apply Global Regulatory and cGMP requirements. Demonstrated technical writing skills. High problem-solving ability/mentality, technically adept and logical. Ability to communicate effectively with peers, department management and cross-functional peers about task status, roadblocks and needs. Ability to work in a fast-paced team environment, meet deadlines, and prioritize work. Advanced knowledge of LIMS, ELN and laboratory data analysis systems preferred. Strong mentoring, coaching, influencing, negotiating and personnel interaction skills.
Key Responsibilities
- Support method transfer/verification/validation and routine testing of in-process, final product, and stability samples
- Perform review of testing data including data packets, final lot file, and COA review
- Anticipate and perform complex troubleshooting and problem solving independently
- Perform data verification, data review and review of GMP documentation for multiple methods and/or products
- Own project, CAPA and deviation/investigation related tasks and/or continuous improvement efforts
- Represent the department in regulatory inspections (internal and external audits)
- Train and mentor others on multiple QC test methods, processes and procedures
- Cross train on multiple complex microbiology methods and/or multiple products
- Author and review/revise technical documents such as test methods, SOPs, specifications, trend reports and/or sample plans
- Perform other tasks as required to support the QC laboratories
Required Qualifications
- Bachelor's degree or equivalent, preferably in Science
- + years of relevant microbiological testing or QC experience or equivalent combination of education and experience
- Demonstrated experience with microbiological techniques
Preferred Qualifications
- Advanced degree
- Experience in a regulated environment
- Advanced knowledge of LIMS, ELN and laboratory data analysis systems
Skills Required
- Ability to accurately and completely understand, follow, interpret and apply Global Regulatory and cGMP requirements
- Demonstrated technical writing skills
- High problem-solving ability/mentality, technically adept and logical
- Ability to communicate effectively with peers, department management and cross-functional peers about task status, roadblocks and needs
- Ability to work in a fast-paced team environment, meet deadlines, and prioritize work
- Strong mentoring, coaching, influencing, negotiating and personnel interaction skills
Locations
- Leiden – NL, United States
Salary
Estimated Salary Rangemedium confidence
60,000 - 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 accurately and completely understand, follow, interpret and apply Global Regulatory and cGMP requirementsintermediate
- Demonstrated technical writing skillsintermediate
- High problem-solving ability/mentality, technically adept and logicalintermediate
- Ability to communicate effectively with peers, department management and cross-functional peers about task status, roadblocks and needsintermediate
- Ability to work in a fast-paced team environment, meet deadlines, and prioritize workintermediate
- Strong mentoring, coaching, influencing, negotiating and personnel interaction skillsintermediate
Required Qualifications
- Bachelor's degree or equivalent, preferably in Science (experience)
- + years of relevant microbiological testing or QC experience or equivalent combination of education and experience (experience)
- Demonstrated experience with microbiological techniques (experience)
Preferred Qualifications
- Advanced degree (experience)
- Experience in a regulated environment (experience)
- Advanced knowledge of LIMS, ELN and laboratory data analysis systems (experience)
Responsibilities
- Support method transfer/verification/validation and routine testing of in-process, final product, and stability samples
- Perform review of testing data including data packets, final lot file, and COA review
- Anticipate and perform complex troubleshooting and problem solving independently
- Perform data verification, data review and review of GMP documentation for multiple methods and/or products
- Own project, CAPA and deviation/investigation related tasks and/or continuous improvement efforts
- Represent the department in regulatory inspections (internal and external audits)
- Train and mentor others on multiple QC test methods, processes and procedures
- Cross train on multiple complex microbiology methods and/or multiple products
- Author and review/revise technical documents such as test methods, SOPs, specifications, trend reports and/or sample plans
- Perform other tasks as required to support the QC laboratories
Tags & Categories
Answer 10 quick questions to check your fit for Scientist, QC Microbiology @ Bristol-Myers Squibb.
10 Questions
~2 Minutes
Instant Score
Related Books and Jobs