Job Details
We are seeking a Quality Control Sample Management Associate II to work with our client 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.
Key Responsibilities (must be familiar with, and can speak to, all below)
- Sample coordination including cross functional collaboration with internal and external labs
- Receipt, processing, distribution and shipment of the following sample types:
- o In-Process, DS, Formulation and DP
- o Equipment cleaning
- o Stability
- o 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
MUST HAVE REQUIREMENTS:
- Education: Bachelor s degree in a relevant scientific discipline
- Experience: At least three 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 skills
- 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 Operating 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.
INTERESTED? APPLY NOW!
FOR MORE IMMEDIATE CONSIDERATION, email a current resume to ...@randstadusa.com
TXT: YOUR NAME and QC to 954-###-####