- Join a growing CRO focused on small molecules, biologics and CGT products
- Exciting opportunity to oversee QA tasks and partake in high level decisions
About Our Client
A preclinical Contract Research Organization is seeking a Quality Assurance Associate to join a growing company.
- Perform administrative and support tasks to assist the Absorption Systems Boston Quality Systems Manager in maintaining all key ASB Quality Systems including but not limited to; Document Control, Training and Qualification Management, Deviation and CAPA Management, Vendor Qualification and Management, Audits and Inspections, Equipment Qualification and Management, Computer System Validation, Archival and Records Management (excluding sample archival), and Tracking and Trending.
- Review Standard Operating Procedures (SOPs), Validation and Sample Analysis Reports, as well as the individual data to assure the highest quality.
- Perform initial intake, documentation, notification, administrative review, tracking, filing, and completion support for events and records related to the above-referenced quality systems.
- Ensure readiness for Quality Systems Manager and Management review.
- Ensure all records are indexed, labeled, tracked, and filed appropriately in paper and electronic format.
- Maintain robust cross-referencing tracking tools with the required information to support Quality Systems Manager review of trends, risks, issues, and gaps.
- Provide reports to the Quality Systems Manager of upcoming, outstanding, and incomplete tasks and events.
- Support ASB technical and laboratory staff in navigating basic QA procedures and escalate issues to Quality Systems Manager when appropriate.
- Assist Quality Systems Manager on all assigned projects, including reconciliation and organization of Legacy information for increased accuracy, reduced error, closure of historical gaps, and ease of access.
MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.
The Successful Applicant
- 1-3 years' experience with a Bachelor's degree in a related field or experience in lieu of a degree.
- High attention to detail with excellent written and verbal communication skills
- Ability to work independently and on teams
- Ability to take direction from, and work with multiple functions, at all levels of the organization
- Excellent computer skills are required, must be proficient in Microsoft Office including Word, Excel (formulas, graphs, and charts), and PowerPoint.
What's on Offer
Offers a variety of benefits allowing employees the opportunity to customize a comprehensive benefits package that meets their personal needs.