What are the responsibilities and job description for the Quality Assurance Lead III position at Integrated Resources, Inc ( IRI )?
Job Description:
Qualifications/ Education & Work Experience
- 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.
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
- Preferred experience with outsourced manufacturing and testing operations
- Working knowledge of MS Office products including Word, Excel, Outlook, PowerPoint, and Project.
