Akkodis is seeking a Quality Assurance Lead III ( Scientific / Pharmaceuticals) for an on-site 12 month contract role for a pharmaceutical company in Waltham, MA. Ideal candidate must have a minimum of 8 years of relevant experience.
Pay/Salary Range: $77.00/hour - $82.00/hour based on experience
Quality Assurance Lead III ( Scientific / Pharmaceuticals) job responsibilities include:
- 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 be requested.
- Assume additional responsibilities as assigned.
QUALIFICATIONS:
- 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.
If you are interested in this Quality Assurance Lead III ( Scientific / Pharmaceuticals) job in Waltham, MA, then please click APPLY NOW. For other opportunities available at Akkodis go to www.akkodis.com. If you have questions about the position, please contact Stephanie Lister at stephanie.lister@akkodisgroup.com.
Equal Opportunity Employer/Veterans/Disabled
Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.
To read our Candidate Privacy Information Statement, which explains how we will use your information, please visit https://www.modis.com/en-us/candidate-privacy/
The Company will consider qualified applicants with arrest and conviction records.
