Quality Assurance Lead III - Integrated Resources, Inc
Waltham, MA 02451
About the Job
Job Description:
" Reviews and approves Master Manufacturing Records, Stability Protocols and Reports, Sampling plans, and associated manufacturing documents for the timely initiation of GMP manufacturing activities.
" Provides Quality oversight and Quality guidance to resolve compliance issues for lots of drug substance, bulk drug product, drug product and clinical materials for use in clinical trials.
" Reviews and Approves Analytical related documents such as Test Methods, Test Method Transfer Plans and Assessments.
" Issue/Review documentation, i.e. Deviations, CAPAs, OOS etc., as they occur.
" Write, revise and perform QA review and approval on SOPs, forms, WI, and other document types.
" Provides iShift support for GMID and BOM approval.
" Support of data analysis and metrics for Quality Council, KPls, and other reportable forums may be requested.
" Assume additional responsibilities as assigned.
Competencies/ Requirements for position
Qualifications/ Education & work experience
" Bachelor's and/or 8+ years of relevant experience
" Minimum 5 years of experience in Quality
" Working knowledge and ability to apply Quality principles and cGMPs in conformance to standards, preferably Producted 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.
" Preferred experience with outsourced manufacturing and testing operations
" Working knowledge of MS Office products including Word, Excel, Outlook, PowerPoint, and Project.
" Reviews and approves Master Manufacturing Records, Stability Protocols and Reports, Sampling plans, and associated manufacturing documents for the timely initiation of GMP manufacturing activities.
" Provides Quality oversight and Quality guidance to resolve compliance issues for lots of drug substance, bulk drug product, drug product and clinical materials for use in clinical trials.
" Reviews and Approves Analytical related documents such as Test Methods, Test Method Transfer Plans and Assessments.
" Issue/Review documentation, i.e. Deviations, CAPAs, OOS etc., as they occur.
" Write, revise and perform QA review and approval on SOPs, forms, WI, and other document types.
" Provides iShift support for GMID and BOM approval.
" Support of data analysis and metrics for Quality Council, KPls, and other reportable forums may be requested.
" Assume additional responsibilities as assigned.
Competencies/ Requirements for position
Qualifications/ Education & work experience
" Bachelor's and/or 8+ years of relevant experience
" Minimum 5 years of experience in Quality
" Working knowledge and ability to apply Quality principles and cGMPs in conformance to standards, preferably Producted 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.
" Preferred experience with outsourced manufacturing and testing operations
" Working knowledge of MS Office products including Word, Excel, Outlook, PowerPoint, and Project.
Source : Integrated Resources, Inc
