We are seeking a contract role in Quality Control Sample Management Associate II based at their Norwood, MA site. The individual in this role will perform cGMP QC sample management activities for QC Chemistry, Microbiology, Bioassay, and various Development labs.
Job Responsibilities
Sample coordination including cross functional collaboration with internal and external labs
Receipt, processing, distribution and shipment of the following sample types:
In-Process, DS, Formulation and DP
Equipment cleaning
Stability
Raw Materials
Coordinating domestic and international sample shipments
Communication with external Contract Test Labs (CTLs)
Interact with Development teams in a GMP compliant manner
Inspect product and raw material retention samples
LIMS (LabVantage) sample logging and result entry
AQL visual inspection of drug product
Stability program support
Controlled temperature unit management, maintenance and troubleshooting
Clean room gowning
Managing/stocking of QC lab supplies
Write/revise SOPs, protocols and reports
Complete and maintain cGMP documentation for work performed
Participate in authoring quality systems records such as deviations, change controls, CAPAs.
Support non-conformance investigations
Establish and maintain a safe laboratory working environment
This position will support first shift QC Sample Management operations, Wednesday through Saturday
Additional duties as may be assigned from time to time
Education & Qualifications
Education: Bachelor's degree in a relevant scientific discipline
Experience: At least two years in a cGMP laboratory setting
Demonstrated aptitude or ability to learn in order to gain a strong understanding of GxP regulations.
General laboratory operations (Pipette and analytical balance use.)
Strong technical writing skill
Proficiency with Microsoft Office Programs
Quick learner with electronic databases (e.g. LIMS, SAP, LMS)
Strong written and oral communication skills as well as organizational skills
General knowledge of industry standards and guidelines for quality control laboratory operation
Demonstrated ability to work effectively under established guidelines and instructions
Ability to collaborate effectively in a dynamic, cross-functional matrix environment.
Be able to follow the relevant Standard Operation Procedures as written.
Ability to efficiently prioritize and complete multiple projects and tasks in a fast-paced environment.
A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.