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Job Requirements of Quality Assurance Lead III:
-
Employment Type:
Contractor
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Location:
Waltham, MA (Onsite)
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Quality Assurance Lead III
Careers Integrated Resources Inc
Waltham, MA (Onsite)
Contractor
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.
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