Deviations Specialist (Boston)

Summary

DPS Group is seeking a Deviations Specialist for a client in Boston, MA

Successful candidates will lead, write, and review deviations and investigations for the client. This includes the manufacturing, facilities, supply chain / materials management and support QC deviations as necessary.

Responsibilities

• Lead, write and review deviations and investigations for the client, including the manufacturing, facilities, supply chain / materials management and support QC deviations as necessary.
• Identify and assemble proper SMEs for triage, determine immediate actions taken, document impact assessments, lead RCA, develop appropriate CAPAs
• Strong knowledge of cGMP requirements for manufacturing
• Experience working in electronic Quality Management System
• Demonstrated understanding of the principles and applications associated with cell and gene manufacturing operations, maintenance / calibration, engineering, and validation
• Deliver On-Time Closure of Deviations to support Batch-On-Time-Delivery commitments for Tech Transfer New Product Introduction, Clinical, and Commercial Products
• Other duties as assigned

Skills And Qualifications

Additional

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and / or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The Company

DPS Group is a global EPCMV firm offering full-service solutions within the Life Sciences (pharmaceutical, biotechnology, and medical technology) and Advanced Technology (semiconductor, data center, and solar) industries. DPS is dedicated to delivering successful projects with a client-first mentality and personal touch across a range of market sectors : Project and Program Management, Procurement, Design, Construction Management, Health and Safety Management, Commissioning, Qualification, and Start-up.

DPS Engineering Inc. is an Equal Opportunity Employer and employment selection decisions are based on merit, qualifications, and abilities. DPS does not discriminate in employment opportunities or practices on the basis of : race, color, religion, gender, national origin, age, sexual orientation, gender identity, disability, veteran status or any other characteristic protected by country, regional or local law.