(Contract) Associate I, Quality Control
Moderna is seeking a 2nd shift Quality Control Sample Management Associate I based at their Norwood, MA site. The individual in this role will perform cGMP QC sample management activities for QC Chemistry, Microbiology, Bioassay. Analytical Development and Drug Product Development labs. Also, this individual may support special projects as assigned.
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
- Raw Materials
- Coordinating domestic and international sample shipments
- Communication with external Contract Test Labs (CTLs)
- Inspect product and raw material retention samples
- LIMS (LabVantage) sample logging and result entry
- AQL visual inspection of drug product
- May perform HPLC (AEX) and NaOH plate reader based assays in support of manufacturing process stat testing as needed
- 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
Here's What You'll Bring to the Table:
- Minimum experience/education required: 5+ years in a cGMP laboratory setting or Bachelor's degree in a relevant scientific discipline with 1+ years in a cGMP laboratory setting preferred
- Minimum knowledge required: cGMPs
- Minimum skills required:
- Technical writing
- Proficiency with Microsoft Office Programs
- Familiarity with electronic databases (e.g. LIMS, SAP, eQMS, EDMS, CMMS, LMS)
- Strong written and oral communication skills as well as organizational skills
- Knowledge of industry standards and guidelines
- Demonstrated ability to work effectively under established guidelines and instructions
- Ability to collaborate effectively in a dynamic, cross-functional matrix environment.
- Working knowledge of relevant and current FDA, EU, ICH guidelines and regulations.
- Ability to efficiently prioritize and complete multiple projects and tasks in a fast-paced environment.
Why join Moderna Therapeutics
We are pioneering a new class of medicines made of messenger RNA, or mRNA. The potential implications of using mRNA as a drug are significant and far-reaching. It could transform not only how certain diseases are treated but also how medicines are discovered, developed and manufactured - at a breadth, scale and speed not common in the biopharma industry.
Since our founding in 2011, we have built the industry's leading mRNA technology platform, the infrastructure to accelerate drug discovery and speed early development, a rapidly expanding pipeline, and an unparalleled team. Our development pipeline includes development candidates for mRNA-based vaccines and therapies spanning several therapeutic areas, and we have multiple clinical trials already underway with other development candidates progressing toward the clinic. In addition, we have a number of discovery programs that are advancing toward the development stage.
We invite you to explore our site to learn more about our company and how we are advancing the promise of mRNA science to improve health and impact lives around the world.
Deliver on the promise of mRNA science to create a new generation of transformative medicines for patients.
Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.