Manufacturing Investigator

2 weeks ago

Boston, United States DPS Group Global Full time

Summary

DPS is looking for a Manufacturing Investigator to support a client in Boston, MA.

Key Responsibilities

  • Lead, write and review deviations and investigations for VCGT, 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

Skills & Qualifications

  • Bachelors or Advanced degree in a scientific discipline.
  • Experience in the pharmaceutical/biotech industry in combination with drug substance/drug product manufacture, development and/or quality.
  • Excellent verbal and written communication skills, detail-oriented personality, and ability to work collaboratively across functions.
  • Experience interacting with regulatory health authorities inspections.
  • Knowledge of global regulations and standards.
  • Strong team player that has a customer service approach and is solution oriented.
  • Attention to detail and the ability to work individually as well as within a multi-disciplinary team.
  • Excellent listening, communication and interpersonal skills fostering team spirit.
  • Consistent delivery of high-quality work at all times.
  • Ability to gown and work in a cleanroom environment.

The Company

DPS Group is a global EPCM 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.

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