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Chemistry Data Reviewer
4 months ago
- Contract Duration 6+ months
- Pay rate up to $0.69 - $42.22/hr
The Role
- Our client is 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:
Here's What You'll Do:
- 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 at ***, Wednesday through Saturday
- Additional duties as may be assigned from time to time
Job Requirements:
Here's What You'll Bring to the Table:
- 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.
Benefits:
- Medical, Vision, and Dental Insurance Plans
- 401k Retirement Fund
About The Company:
- Our client operates as a developer of messenger RNA therapeutics. The company develops and discovers drugs that produce proteins or antibodies inside patient cells. Its pipeline includes various drug modalities such as prophylactic vaccines, therapeutic vaccines, intratumoral immuno-oncology, localized therapeutics, and liver intracellular. Through its mRNA therapeutics platform, they develop and produce human proteins, antibodies, and Client proteins, which help in preventing, treating, and curing diseases. It also develops therapeutics in the areas of infectious disease, rare liver disease, immuno-oncology, and cardiovascular disease.
- mRNA is now a turning point in the history of science, medicine, technology, and even humankind itself. With this breakthrough discovery, many of the world's biggest and most challenging medical problems are no longer a question of "how?” but merely a question of "when?”
- Come with us as we pursue the uncharted reaches of possibility and make your mark on the future of medicine.
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