Devens,
MA
01434
US
Posted: 08/14/2023
2023-08-14
2023-10-31
Job Number: 24712329
Job Description
MANUFACTURING COMPLIANCE SPECIALIST
DEVENS, MA
Hybrid Role-50% onsite and 50% remote.
Required bachelor's degree.
Looking for 1-4 years of experience in investigations.
The pay ranges between $49.47 to $51.30 per hour.
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 .
Required Skills:
- BS in chemical/biochemical engineering, biological sciences, or a related discipline with 2-4 years relevant experience .
- Looking for 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 .
This 6+ month position starts ASAP.
Please E-MAIL your resume (attachment to email) with rate and availability to Krysty: krysty@alphaconsulting.Com
ALPHA'S REQUIREMENT #23-01372
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE
#LI-AA1
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