ISPE Boston Area Chapter
Quality Assurance Specialist IV / QA Senior Specialist
ISPE Boston Area Chapter, Fall River, Massachusetts, us, 02720
Overview
The QA Specialist IV / QA Senior Specialist supports Quality Assurance functions focused on external manufacturing operations. The position will review/audit complex external documents including batch records, process protocols, reports and quality system documentation: ensure compliance to defined Quality System procedures; conduct complex information analysis; assure compliance to CFRs by performing internal and external audits; revise standard operating procedures and associated documentation.
Responsibilities
Review and approve Quality System Documentation, including deviations and QC investigations
Support Phase I/II/III Clinical Manufacturing Campaigns and Clinical Shipments
Write, review, and/or approve SOPs, Batch Records, Material Specs and Test Records
Perform data and document review for Manufacturing Campaigns and shipments including Batch
Records, Solution Records, Test Records and Packaging records
Support the Stability Program through review of Protocols, Reports and Data
Support the Validation Program with review of Protocols and Reports
Perform review of INDs for submission
Conduct audits, Internal and External (Vendors, Suppliers, Sub-Contractor Testing Facilities)
Trend and report external QA related information (Deviations, CAPAs, EM excursions,
Deviations, Change Controls etc.)
Assist with disposition of Clinical Product and Cell Banks
Review and approve external vendor changes
Review and approve external protocols including Manufacturing, Test Method, Equipment and
Process Validations (IQ, OQ, and PQs, Cleaning Validation)
Review method and process reports for compliance
Assist departments with investigations related to manufactured products
Willingness to travel
Perform other job-related functions as needed
Qualifications
Bachelor Science degree in Chemistry/Biology or related discipline
10+ years QA experience in Biotech/Pharma industry or combination of internal and external clinical QA experience
Strong understanding of QC test methods, stability procedures and environmental monitoring programs
Strong compliance knowledge of GMP Quality Systems, policies, and regulations
Strong working knowledge of CFRs and ICH guidelines
Strong understanding of Biopharmaceutical Manufacturing Operations (Cell Culture and Purification)
Internal/external auditing experience
External manufacturing experience
Review of validation documentation and 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
The ability to work independently and as part of a team
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The QA Specialist IV / QA Senior Specialist supports Quality Assurance functions focused on external manufacturing operations. The position will review/audit complex external documents including batch records, process protocols, reports and quality system documentation: ensure compliance to defined Quality System procedures; conduct complex information analysis; assure compliance to CFRs by performing internal and external audits; revise standard operating procedures and associated documentation.
Responsibilities
Review and approve Quality System Documentation, including deviations and QC investigations
Support Phase I/II/III Clinical Manufacturing Campaigns and Clinical Shipments
Write, review, and/or approve SOPs, Batch Records, Material Specs and Test Records
Perform data and document review for Manufacturing Campaigns and shipments including Batch
Records, Solution Records, Test Records and Packaging records
Support the Stability Program through review of Protocols, Reports and Data
Support the Validation Program with review of Protocols and Reports
Perform review of INDs for submission
Conduct audits, Internal and External (Vendors, Suppliers, Sub-Contractor Testing Facilities)
Trend and report external QA related information (Deviations, CAPAs, EM excursions,
Deviations, Change Controls etc.)
Assist with disposition of Clinical Product and Cell Banks
Review and approve external vendor changes
Review and approve external protocols including Manufacturing, Test Method, Equipment and
Process Validations (IQ, OQ, and PQs, Cleaning Validation)
Review method and process reports for compliance
Assist departments with investigations related to manufactured products
Willingness to travel
Perform other job-related functions as needed
Qualifications
Bachelor Science degree in Chemistry/Biology or related discipline
10+ years QA experience in Biotech/Pharma industry or combination of internal and external clinical QA experience
Strong understanding of QC test methods, stability procedures and environmental monitoring programs
Strong compliance knowledge of GMP Quality Systems, policies, and regulations
Strong working knowledge of CFRs and ICH guidelines
Strong understanding of Biopharmaceutical Manufacturing Operations (Cell Culture and Purification)
Internal/external auditing experience
External manufacturing experience
Review of validation documentation and 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
The ability to work independently and as part of a team
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