Address
Form of workJob Description
Hybrid Role
The Quality Assurance Specialist reports to the Lot Manager
" Person in Plant for Manufacturing runs.
" Perform lot release Quality Review of manufacturing and quality control records to ensure compliance with specifications and regulations.
" Reviews and approves master production records for the timely initiation of GMP manufacturing activities.
" Reviews executed batch records and related documentation, resolves compliance issues and dispositions lots of drug substance, bulk drug product, drug product and clinical materials for use in clinical trials
" Perform lot release Quality Review of manufacturing and quality control records to ensure compliance with specifications and regulations.
" Ensure that all requirements, as stipulated in the appropriate QTA, have been met.
" Issue/Review documentation, i.e. Deviations, CAPAs, OOS etc., as they occur.
" Write and revise SOP, forms, WI, and any other document types
" Assist with internal and external audits.
" Lead compiling data analysis and metrics for QMR, KPIs, and other reportable forums may be requested.
" Assume additional responsibilities as assigned.
Qualifications/ Education & work experience
" Bachelor's and/or 8+ years of relevant experience
" Minimum 5 years of experience in Quality Assurance
" Working knowledge and ability to apply Quality principles and cGMPs in conformance to standards, preferably gained from working in a manufacturing, QA or QC environment.
" Demonstrated ability to interact and communicate effectively, both written and verbal, with peers, management, auditors, and consultants.
" Must have excellent attention to detail, project and time management skills, and the ability to manage multiple priorities with aggressive timelines.
" Working knowledge of MS Office products including Word, Excel, Outlook, PowerPoint, and Project.
" Excellent communications skills both written and verbal.
" Effective time management and organizational skills.
" Strong attention to details and ability to lead others in a team setting.
" Ability to gown and enter clean rooms
" Perform review of Batch records and associated documents in support of the release of a product.
" Review of Analytical data
" Perform QA presence on the floor/person in the plant
" Ensure that documentation and operations meet established requirements of cGMPs, Internal
" SOPs, and company policies.
" Draft and revise procedures as required.
" Performs work that requires decision-making and the consistent exercise of independent judgment and discretion
The Quality Assurance Specialist reports to the Lot Manager
" Person in Plant for Manufacturing runs.
" Perform lot release Quality Review of manufacturing and quality control records to ensure compliance with specifications and regulations.
" Reviews and approves master production records for the timely initiation of GMP manufacturing activities.
" Reviews executed batch records and related documentation, resolves compliance issues and dispositions lots of drug substance, bulk drug product, drug product and clinical materials for use in clinical trials
" Perform lot release Quality Review of manufacturing and quality control records to ensure compliance with specifications and regulations.
" Ensure that all requirements, as stipulated in the appropriate QTA, have been met.
" Issue/Review documentation, i.e. Deviations, CAPAs, OOS etc., as they occur.
" Write and revise SOP, forms, WI, and any other document types
" Assist with internal and external audits.
" Lead compiling data analysis and metrics for QMR, KPIs, and other reportable forums may be requested.
" Assume additional responsibilities as assigned.
Qualifications/ Education & work experience
" Bachelor's and/or 8+ years of relevant experience
" Minimum 5 years of experience in Quality Assurance
" Working knowledge and ability to apply Quality principles and cGMPs in conformance to standards, preferably gained from working in a manufacturing, QA or QC environment.
" Demonstrated ability to interact and communicate effectively, both written and verbal, with peers, management, auditors, and consultants.
" Must have excellent attention to detail, project and time management skills, and the ability to manage multiple priorities with aggressive timelines.
" Working knowledge of MS Office products including Word, Excel, Outlook, PowerPoint, and Project.
" Excellent communications skills both written and verbal.
" Effective time management and organizational skills.
" Strong attention to details and ability to lead others in a team setting.
" Ability to gown and enter clean rooms
" Perform review of Batch records and associated documents in support of the release of a product.
" Review of Analytical data
" Perform QA presence on the floor/person in the plant
" Ensure that documentation and operations meet established requirements of cGMPs, Internal
" SOPs, and company policies.
" Draft and revise procedures as required.
" Performs work that requires decision-making and the consistent exercise of independent judgment and discretion
