- Performing routine analytical chemistry data review and reporting of data generated through laboratory tests including HPLC, GC, UV, Particle Analysis, Dynamic Light Scattering, Osmolality, pH, Appearance etc.
- Perform data review and verification in multiple LIMS and ELN applications.
- Ensure all laboratory tests are performed correctly and meets suitability and acceptance requirements.
- Maintain data review prioritization trackers ensuring on time execution of the assigned data review and data management task.
- Communicate the OOS/OOT/OOE cases to the investigations team promptly to ensure the chemistry labs comply with investigation/aberrant data SOP guidelines.
- Supports investigation activities, follow-up and follow through the investigation and closure to approve the final data set.
- Interact with other analysts when corrections are identified as part of the data review process. Follow up and confirm corrections were made.
- Creating, revising, reviewing, and approving and/or support Certificate of Analysis generation workflows as needed.
- Participates in project meetings to provide status updates to stakeholders.
- Provides prompt communication of risk and mitigation for all data management related deliverables.
- Assist in test scheduling as necessary (e.g., when tests need to be repeated based on data review) to meet the project timelines.
- Work on continuous improvement for data review requirements and processes to ensure delivery of highest quality of data.
- Establish and maintain a safe working environment.
- Additional duties as may be assigned from time to time
- BA/BS in Chemistry (preferred) or other relevant scientific discipline
- 0-2 years in laboratory setting with in pharmaceutical QC analytical chemistry and data review.
- Technical experience: Familiarity with LIMs systems, ELN, Chromeleon, Veeva, JMP and other laboratory software systems
- Strong attention to detail, effective communication skill and an ability to remove viscosity.
- Collaborative: You will need to maintain a strong level of collaboration and communication across multiple testing teams to remain focus
- Pivot Fearlessly: You will navigate through the complexities of analytical operations in-process, release and testing team, adapting to new challenges and data with agility.
- Pursue Options in Parallel: Your role demands managing multiple data priority types and multiple regulatory filing dates simultaneously to ensure the most efficient outcomes.
- A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.
Sr. Research Associate - Norwood, United States - Randstad Life Sciences US
Description
6 Month Contract
Norwood, MA
PR: $40-45/hour
Job Summary
Moderna is seeking a contract Sr. Research Associate/ Specialist in the Analytical Technical Operations (ATO) team based at their Norwood, MA facility. The individual in this role will be primarily responsible for review of data generated by our Analytical Technical Operations team supporting our in-process testing, STAT, priority, release, and stability workflows. The individual candidate may also be responsible for review and transcription of data generated by our internal and external testing partners. The candidate must thrive in a fast-paced environment, have a collaborative spirit, and be curious and willing to learn new techniques to push process development forward.
Job Responsibilities
Education & Qualifications
Required
Preferred