The Planet Group
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Responsibilities
· Execute day to day operations of the stability activities through sample receipts, aliquoting, stability sample set-down, data compilation,
· Responsible for authoring of stability protocols to establishing our Internal stability management capabilities.
· Provide oversight to CMOs/CTLs to ensure that studies conducted externally are executed compliantly and studies are set down on time
· Responsible for entering stability data into slide decks, and spreadsheets
· Responsible for the resolution and on-time completion of stability-related deviations, CAPAs, and Change Controls by providing technical expertise, as appropriate.
· Responsible for managing the shipment of stability materials to different sites as needed
· Responsible for generating, updating, and stability-related SOPs, as appropriate.
· Responsible for ensuring that the stability-related forms / documents adhere to GXP requirements and internal SOPs.
· Other duties as assigned.
Requirements
· 2-5 years’ experience in a GxP environment
· Bachelors in a Life Science
· Scientific background in Stability or Analytics for Biologics
· Experience with LIMS preferred
QC Stability Specialist
19 Presidential Way, Suite 202 Woburn, MA 01801 US
Posted: 12/27/2022
2022-12-27
2023-02-25
Employment Type:
Contract
Job Number: 522984-1
Country: United States
Is job remote?: No
Job Description
Responsibilities
· Execute day to day operations of the stability activities through sample receipts, aliquoting, stability sample set-down, data compilation,
· Responsible for authoring of stability protocols to establishing our Internal stability management capabilities.
· Provide oversight to CMOs/CTLs to ensure that studies conducted externally are executed compliantly and studies are set down on time
· Responsible for entering stability data into slide decks, and spreadsheets
· Responsible for the resolution and on-time completion of stability-related deviations, CAPAs, and Change Controls by providing technical expertise, as appropriate.
· Responsible for managing the shipment of stability materials to different sites as needed
· Responsible for generating, updating, and stability-related SOPs, as appropriate.
· Responsible for ensuring that the stability-related forms / documents adhere to GXP requirements and internal SOPs.
· Other duties as assigned.
Requirements
· 2-5 years’ experience in a GxP environment
· Bachelors in a Life Science
· Scientific background in Stability or Analytics for Biologics
· Experience with LIMS preferred
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