Quality Assurance Specialist I-IV
Princeton, New Jersey, United States
Job Summary
Occupation
Healthcare-Quality Control/Quality Assurance
Specialty
Quality Assurance Specialist
Location
08540, Princeton, New Jersey, United States
Visa Sponsorship
No
Job Description
Last Update:
1/11/24
NJ Bio is hiring a Quality Assurance Specialist I-IV. This individual will support clinical manufacturing operations. This individual will provide oversight of manufacturing activities from a quality perspective with limited supervision.
Oversight (with limited supervision) of clinical manufacturing activities (phase 1, phase 2 of APIs, ADCs), including area clearance, issuance, and review of batch records, and making decisions on initiation of deviations and investigations.
Oversight (with limited supervision), review, and approval of Materials Management and supply activities.
Revision and/or review and approval of SOPs, Protocols, Reports, and Batch Records for continuous improvement.
Support of Environmental Monitoring Program including Controlled Environments and Clean Utilities.
Initiation of Discrepancies, including Deviations and Investigations
Support of implementation of CAPA as determined.
Review and approval of Certificates of Analysis for Raw Materials, Intermediates, and Finished Goods.
Disposition of controlled materials (Work in Progress, Finished Product, and Raw Materials)
Provide basic support during compliance inspections conducted by external sources (i.e. health authorities)
Support GMP manufacturing shifts as needed, including participation in shift change/floor meetings with the operators.
Perform other job-related functions as needed.
Required Knowledge, Skills and Abilities
Able to handle multiple client projects for Quality requirements.
Strong knowledge of Microsoft Word, Excel, and Power Point.
Strong written and interpersonal communication skills.
Ability to write and present reports/investigations and host meetings to support Quality Systems
Ability to train employees in a small group setting.
The ability to work independently and as part of a team.
Required Education and Experience
Bachelor Science degree in Chemistry/Biology or related discipline
0-5 years QA experience in Biotech/Pharma industry or combination of QA/MFG or QC experience or in GMP environment. Level at hire will be based on years of experience.
Working knowledge of GMPs and their application to biotech/pharma/phase 1 and 2 clinical manufacturing
Strong compliance knowledge of GMP Quality Systems, policies, and regulations
Must be able to interpret applicable GMP standards and objectively decide on items with management support.
Individual may be required to sit, stand, walk regularly and occasionally lift 0-15 pounds.
Oversight (with limited supervision) of clinical manufacturing activities (phase 1, phase 2 of APIs, ADCs), including area clearance, issuance, and review of batch records, and making decisions on initiation of deviations and investigations.
Oversight (with limited supervision), review, and approval of Materials Management and supply activities.
Revision and/or review and approval of SOPs, Protocols, Reports, and Batch Records for continuous improvement.
Support of Environmental Monitoring Program including Controlled Environments and Clean Utilities.
Initiation of Discrepancies, including Deviations and Investigations
Support of implementation of CAPA as determined.
Review and approval of Certificates of Analysis for Raw Materials, Intermediates, and Finished Goods.
Disposition of controlled materials (Work in Progress, Finished Product, and Raw Materials)
Provide basic support during compliance inspections conducted by external sources (i.e. health authorities)
Support GMP manufacturing shifts as needed, including participation in shift change/floor meetings with the operators.
Perform other job-related functions as needed.
Required Knowledge, Skills and Abilities
Able to handle multiple client projects for Quality requirements.
Strong knowledge of Microsoft Word, Excel, and Power Point.
Strong written and interpersonal communication skills.
Ability to write and present reports/investigations and host meetings to support Quality Systems
Ability to train employees in a small group setting.
The ability to work independently and as part of a team.
Required Education and Experience
Bachelor Science degree in Chemistry/Biology or related discipline
0-5 years QA experience in Biotech/Pharma industry or combination of QA/MFG or QC experience or in GMP environment. Level at hire will be based on years of experience.
Working knowledge of GMPs and their application to biotech/pharma/phase 1 and 2 clinical manufacturing
Strong compliance knowledge of GMP Quality Systems, policies, and regulations
Must be able to interpret applicable GMP standards and objectively decide on items with management support.
Individual may be required to sit, stand, walk regularly and occasionally lift 0-15 pounds.