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Senior Manufacturing Compliance Specialist

Devens, MA

Posted: 01/17/2023 Job Number: 22868103

Job Description

SENIOR MANUFACTURING COMPLIANCE SPECIALIST
DEVENS, MA
Hybrid Role.

Required Skills:
  • BS in chemical/biochemical engineering, biological sciences, or a related discipline with 2-4 years relevant experience (or equivalent).
  • 1-4 years of experience in investigations.
  • Prior experience in leading cGMP investigations utilizing formal Root Cause Analysis tools preferred.
  • Demonstrated basic project management skills (organization, collaboration, multi-tasking, and communication), attention to detail, and the ability to perform well in a team-based environment are required.
  • Excellent verbal & written communications skills, including ability to present information clearly and concisely.
  • Excellent interpersonal and collaboration skills necessary to interface with and influence all levels of the organization.
  • Prior experience with SOPs, cGMPs and the know how to work within a regulatory environment.
  • Prior experience in/Knowledge of cell culture, recovery, and/or purification biopharmaceutical manufacturing preferred.

Project Description:
  • Conducts and manages resolution of deviations, root cause investigations, impact assessments and CAPAs as a Lead Investigator.
  • Liaises with many different groups/organizations as a Lead Investigator.
  • Proactively identifies and facilitates resolution of obstacles to timely completion.
  • Proactively manages progression of investigation and CAPA to timely closure.
  • Leads and participates in cross-functional investigation teams.
  • Presents investigation findings to key stakeholders and site management.
  • Uses Quality Risk Management and Operational Excellence principles to facilitate risk-based decision-making, drive continuous improvement, and eliminate waste.

This 12+ month position starts ASAP.

Please E-MAIL your resume (attachment to email) with rate and availability to Rose: Rose@alphaconsulting.Com

ALPHA'S REQUIREMENT #23-00133
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE

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Rose Minchello

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