Production - Compliance Specialist - Deviation/Investigation - Net2Source

Position Title: Compliance Specialist - Deviation/Investigation
Location: Devens, MA
Duration: 6+ months (contract)

Pay Rate: $ 45 - 50/hour on W2

Job Description: Onsite
Top Must Haves: 1-3 years of experience in investigations and a Bachelor's Degree.

Major Duties and Responsibilities:
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.

Knowledge and Skill:
Required BS in chemical/biochemical engineering, biological sciences, or a related discipline with 1-3 years relevant experience.
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.