Location: Waltham,MA, USA
1 Year Contract
Hybrid
Shift: Mon-Fri 8am-5pm or 9am-6pm
Job Responsibilities
• 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 (out of spec) etc., as they occur.
• Write and revise SOP, forms, WI, and any other document types
• Assist with internal and external audits.
• Support of data analysis and metrics for QMR, KPIs, and other reportable forums may be requested.
• Assume additional responsibilities as assigned.
• 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.
• Support of data analysis and metrics for QMR, KPIs, and other reportable forums may be requested.
Education & Qualifications
• Bachelor's and/or 8+ years of relevant experience
• Minimum 5 years of experience in Quality Assurance (Prefer Lot release experiences)
• 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.
Must Have Experience:
• Bachelor's and/or 8+ years of relevant experience
• Minimum 5 years of experience in Quality Assurance (Prefer Lot release experiences) – must be specific to pharm industry
• PHD may be considered overqualified
Nice to Have Experience:
• Investigation or product complaint experience