Specialist QC Systems and Support
Bristol-Myers Squibb
Specialist QC Systems and Support
Job Description
Manage QC equipment lifecycle related tasks in collaboration with QC laboratories, Site Engineering, Facility Services, and other departments Keeping the equipment in the laboratory in cGMP state including facilitation of validation, calibration, maintenance, repairs of the equipment as well as computerized system related tasks in accordance with GMP requirements and written procedures Provides basic and first-line equipment troubleshooting Perform document revision, CAPA, and support projects and continuous improvement efforts Support initiation, assessment and review of deviations and change controls Perform other tasks as required to support the QC laboratories Ability to accurately and completely understand, follow, interpret and apply Global Regulatory and cGMP requirements. Ability to communicate effectively with peers and management regarding task completion, roadblocks, and needs. Attention to detail and demonstrated organizational skills. Ability to work in a fast-paced team environment, meet deadlines and changing priorities. Problem-solving ability/mentality, technically adept and logical Bachelor's degree preferred in science. Combination of education and work experience may be considered (HLO or equivalent). 4+ years of relevant laboratory experience or equivalent combination of education and experience, preferably in a regulated environment. Demonstrated experience within a GMP environment. Experience with writing technical documents and standard operation procedures. Knowledge of computerized systems and enterprise applications such as Valgenesis, LIMS preferred. Knowledge of instrument lifecycle management in GMP environment.
Key Responsibilities
- Manage QC equipment lifecycle related tasks in collaboration with QC laboratories, Site Engineering, Facility Services, and other departments
- Keep the equipment in the laboratory in cGMP state including facilitation of validation, calibration, maintenance, repairs of the equipment
- Perform computerized system related tasks in accordance with GMP requirements and written procedures
- Provide basic and first-line equipment troubleshooting
- Perform document revision, CAPA, and support projects and continuous improvement efforts
- Support initiation, assessment and review of deviations and change controls
- Perform other tasks as required to support the QC laboratories
Required Qualifications
- Bachelor's degree preferred in science
- Combination of education and work experience may be considered (HLO or equivalent)
- + years of relevant laboratory experience or equivalent combination of education and experience, preferably in a regulated environment
- Demonstrated experience within a GMP environment
Preferred Qualifications
- Knowledge of computerized systems and enterprise applications such as Valgenesis, LIMS
- Knowledge of instrument lifecycle management in GMP environment
Skills Required
- Ability to accurately and completely understand, follow, interpret and apply Global Regulatory and cGMP requirements
- Ability to communicate effectively with peers and management regarding task completion, roadblocks, and needs
- Attention to detail and demonstrated organizational skills
- Ability to work in a fast-paced team environment, meet deadlines and changing priorities
- Problem-solving ability/mentality, technically adept and logical
- Experience with writing technical documents and standard operation procedures
Locations
- Leiden – NL, United States
Salary
Salary not disclosed
Estimated Salary Rangemedium confidence
75,000 - 120,000 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
- Ability to communicate effectively with peers and management regarding task completion, roadblocks, and needsintermediate
- Attention to detail and demonstrated organizational skillsintermediate
- Ability to work in a fast-paced team environment, meet deadlines and changing prioritiesintermediate
- Problem-solving ability/mentality, technically adept and logicalintermediate
- Experience with writing technical documents and standard operation proceduresintermediate
Required Qualifications
- Bachelor's degree preferred in science (experience)
- Combination of education and work experience may be considered (HLO or equivalent) (experience)
- + years of relevant laboratory experience or equivalent combination of education and experience, preferably in a regulated environment (experience)
- Demonstrated experience within a GMP environment (experience)
Preferred Qualifications
- Knowledge of computerized systems and enterprise applications such as Valgenesis, LIMS (experience)
- Knowledge of instrument lifecycle management in GMP environment (experience)
Responsibilities
- Manage QC equipment lifecycle related tasks in collaboration with QC laboratories, Site Engineering, Facility Services, and other departments
- Keep the equipment in the laboratory in cGMP state including facilitation of validation, calibration, maintenance, repairs of the equipment
- Perform computerized system related tasks in accordance with GMP requirements and written procedures
- Provide basic and first-line equipment troubleshooting
- Perform document revision, CAPA, and support projects and continuous improvement efforts
- Support initiation, assessment and review of deviations and change controls
- Perform other tasks as required to support the QC laboratories
Tags & Categories
Specialist QC Systems and Support
Bristol-Myers Squibb
Specialist QC Systems and Support
Job Description
Manage QC equipment lifecycle related tasks in collaboration with QC laboratories, Site Engineering, Facility Services, and other departments Keeping the equipment in the laboratory in cGMP state including facilitation of validation, calibration, maintenance, repairs of the equipment as well as computerized system related tasks in accordance with GMP requirements and written procedures Provides basic and first-line equipment troubleshooting Perform document revision, CAPA, and support projects and continuous improvement efforts Support initiation, assessment and review of deviations and change controls Perform other tasks as required to support the QC laboratories Ability to accurately and completely understand, follow, interpret and apply Global Regulatory and cGMP requirements. Ability to communicate effectively with peers and management regarding task completion, roadblocks, and needs. Attention to detail and demonstrated organizational skills. Ability to work in a fast-paced team environment, meet deadlines and changing priorities. Problem-solving ability/mentality, technically adept and logical Bachelor's degree preferred in science. Combination of education and work experience may be considered (HLO or equivalent). 4+ years of relevant laboratory experience or equivalent combination of education and experience, preferably in a regulated environment. Demonstrated experience within a GMP environment. Experience with writing technical documents and standard operation procedures. Knowledge of computerized systems and enterprise applications such as Valgenesis, LIMS preferred. Knowledge of instrument lifecycle management in GMP environment.
Key Responsibilities
- Manage QC equipment lifecycle related tasks in collaboration with QC laboratories, Site Engineering, Facility Services, and other departments
- Keep the equipment in the laboratory in cGMP state including facilitation of validation, calibration, maintenance, repairs of the equipment
- Perform computerized system related tasks in accordance with GMP requirements and written procedures
- Provide basic and first-line equipment troubleshooting
- Perform document revision, CAPA, and support projects and continuous improvement efforts
- Support initiation, assessment and review of deviations and change controls
- Perform other tasks as required to support the QC laboratories
Required Qualifications
- Bachelor's degree preferred in science
- Combination of education and work experience may be considered (HLO or equivalent)
- + years of relevant laboratory experience or equivalent combination of education and experience, preferably in a regulated environment
- Demonstrated experience within a GMP environment
Preferred Qualifications
- Knowledge of computerized systems and enterprise applications such as Valgenesis, LIMS
- Knowledge of instrument lifecycle management in GMP environment
Skills Required
- Ability to accurately and completely understand, follow, interpret and apply Global Regulatory and cGMP requirements
- Ability to communicate effectively with peers and management regarding task completion, roadblocks, and needs
- Attention to detail and demonstrated organizational skills
- Ability to work in a fast-paced team environment, meet deadlines and changing priorities
- Problem-solving ability/mentality, technically adept and logical
- Experience with writing technical documents and standard operation procedures
Locations
- Leiden – NL, United States
Salary
Salary not disclosed
Estimated Salary Rangemedium confidence
75,000 - 120,000 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
- Ability to communicate effectively with peers and management regarding task completion, roadblocks, and needsintermediate
- Attention to detail and demonstrated organizational skillsintermediate
- Ability to work in a fast-paced team environment, meet deadlines and changing prioritiesintermediate
- Problem-solving ability/mentality, technically adept and logicalintermediate
- Experience with writing technical documents and standard operation proceduresintermediate
Required Qualifications
- Bachelor's degree preferred in science (experience)
- Combination of education and work experience may be considered (HLO or equivalent) (experience)
- + years of relevant laboratory experience or equivalent combination of education and experience, preferably in a regulated environment (experience)
- Demonstrated experience within a GMP environment (experience)
Preferred Qualifications
- Knowledge of computerized systems and enterprise applications such as Valgenesis, LIMS (experience)
- Knowledge of instrument lifecycle management in GMP environment (experience)
Responsibilities
- Manage QC equipment lifecycle related tasks in collaboration with QC laboratories, Site Engineering, Facility Services, and other departments
- Keep the equipment in the laboratory in cGMP state including facilitation of validation, calibration, maintenance, repairs of the equipment
- Perform computerized system related tasks in accordance with GMP requirements and written procedures
- Provide basic and first-line equipment troubleshooting
- Perform document revision, CAPA, and support projects and continuous improvement efforts
- Support initiation, assessment and review of deviations and change controls
- Perform other tasks as required to support the QC laboratories
Tags & Categories