Summary:
A global leader in biotech specializing in healthcare solutions for targeted debilitating diseases is looking for a QC Assistant to join the QC Lab in Cambridge, MA. The company is most notably known for its contributions in neurology, endocrinology and urology-oncology. The QC Assistant's primary responsibility will be to support the QC Lab in the activities for the release and stability testing for a commercially approved drug for treatment of Pancreatic cancer. This is a 6+ month contract role with possible extensions and full benefits.
Responsibilities:
- Perform testing and review of in-process, external lab data, release and stability for lipid products under cGMP compliance.
- Maintain laboratory inventories for supplies and preparation of reagents or buffers.
- Identify and assist in troubleshooting aberrant data, maintain validated equipment.
- Support guidance on investigations for Quality Instances, CAPAs, and CCs.
- Support the filing and storage of laboratory data.
- Support the general lab cleanliness and compliance.
Requirements:
- Bachelor's degree in Analytical Chemistry or Microbiology.
- 2+ years of professional experience in a QC lab.
- Background in performing HPLC based assays for proteins, lipids, and/or small molecules under cGMPs.
- Demonstrated experience in GMP quality systems.
- Working knowledge of Particle Size, pH, Osmolality, IVR, UV vis and other standard wet chemistry methods.
- Knowledge of SAP or Empower is desired.
- Ability to work with minimal supervision as well as in a team environment.
- Self-motivated and desire to learn.
- Strong organizational and presentation skills.
This is a 6+ month contract role with possible extensions and full benefits.
