- The primary focus of the QC Associate I is to provide support for sample management and routine laboratory operations.
- This role is responsible for performing and coordinating sample accessioning, testing, shipping and data handling. Primary responsibilities include: Coordinating the logistics of sample receipt, internal testing and external testing.
- Delivering samples to internal testing labs prioritized by required turnaround times.
- Shipping samples to external test labs and preparing associated paperwork. Assembling QC test data packets for lot release.
- Performing inventory maintenance. Maintaining QC data files and perform data archival as required.
- Maintaining instrumentation and supporting documentation in a GMP compliant manner. Responding to equipment alarms and performing equipment maintenance tasks.
Additional Job Requirements:
- BS with minimum of 3-4 years of experience in a GMP QC lab is required (or equivalent experience in a related biopharmaceutical GLP or GMP lab environment).
- Experience with LIMS and Smart lab computer applications a plus.
- Proficient in common computer software applications, including Empower, and effective communication skills, both oral and written are needed.
- Candidate must have strong general laboratory and organizational skills, attention to detail, flexibility, and the ability to work as part of a team.
- Position Handles Hazardous Materials