USA-Quality Assurance Associate II (Scientific) - The Fountain Group
Waltham, MA
About the Job
Pay: $48
Job Description:
• Review and approve Master Manufacturing Records, Stability Protocols and Reports, Sampling plans, and associated manufacturing documents for the timely initiation of GMP manufacturing activities.
• Perform QA review of Executed Batch Records.
• Perform QA review of Quality Records, i.e. Deviations, CAPAs, OOS etc., as they occur.
• Perform QA review and approval on SOPs, forms, WI, and other document types.
• Provide SAP support for GMID and BOM approval.
• Provide 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.
• Ensure all requirements, stipulated in the CMO Quality Agreements, are being met.
• Review and Approve Analytical related documents such as Test Methods, Test Method Transfer Plans and Assessments, if needed.
• Participate in Quality Risk Assessments
• Assist with internal and external audits.
• 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 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.
• Preferred experience with outsourced manufacturing and testing operations
• Working knowledge of MS Office products including Word, Excel, Outlook, PowerPoint, and Project.
Job Description:
• Review and approve Master Manufacturing Records, Stability Protocols and Reports, Sampling plans, and associated manufacturing documents for the timely initiation of GMP manufacturing activities.
• Perform QA review of Executed Batch Records.
• Perform QA review of Quality Records, i.e. Deviations, CAPAs, OOS etc., as they occur.
• Perform QA review and approval on SOPs, forms, WI, and other document types.
• Provide SAP support for GMID and BOM approval.
• Provide 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.
• Ensure all requirements, stipulated in the CMO Quality Agreements, are being met.
• Review and Approve Analytical related documents such as Test Methods, Test Method Transfer Plans and Assessments, if needed.
• Participate in Quality Risk Assessments
• Assist with internal and external audits.
• 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 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.
• Preferred experience with outsourced manufacturing and testing operations
• Working knowledge of MS Office products including Word, Excel, Outlook, PowerPoint, and Project.
Source : The Fountain Group