Quality Assurance Associate II (Scientific)
- Katalyst HealthCares & Life Sciences
- South Waltham, MA
- Closing date
- May 29, 2023
- Science, Pharmaceutical, Quality Assurance
- Organization Type
- 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
- SME for Quality in vendor meetings for raw materials, excipients, cell banks and plasmids
- 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.
- Bachelor's degree and/or 10+ years of relevant experience; Masters preferred
- Minimum 8 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.
- 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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