QA Lead Technical Operations - Axelon Services Corporation

Job Description:

QA Lead Technical Operations, Projects
Onsite, Devens location
Work Schedule: Mon - Fri, First shift (8:30AM - 5PM)

Job Description/ Responsibilities:
- Provides Quality Assurance (QA) support to Devens Site and reporting Manger through quality review and
approval of Investigations and Corrective Actions.
- Decision making of non-conformance through a deep understanding of Quality Systems Regulatory expectations
- Reviews and approves Quality, Quality Control, Validation and Automation related documents
- Review and approves Standard Operating Procedures (SOPs).
- Review and approval of Validation related documentation such as risk assessments, protocols and test scripts and
summary reports.
- Review and approval of change proposals as well as associated deliverables, ensuring the change deliverables meet
external regulatory and internal WWQC guidelines and requirements.
- Ability to coach across different departments within the subject matter of Investigations, CAPAs, general risk
assessments and Validation.
- Ability to self-manage and prioritize work across multiple competing deliverables, in a remote working
environment
- Able to interpret complicated data and make sound decisions, Independently