Reporting to the Solid Quality Control (QC) Unit, the QC Associate is responsible for day to day operations related to sample submission and data management in support of QC GMP and cross-functional development. The candidate will maintain documentation in accordance with internal data entry, analysis and trending SOPs. In addition, coordinate domestic and international biologic sample shipments (at room temperature, on dry ice, or in liquid nitrogen) according to applicable guidelines.
Key Duties & Accountabilities:
- Manage the day to day operations of retrieving data from Contract Testing Laboratories or in-house analytical labs, ensuring a timely, effective, and compliant data trending and archival in support of Solid operations
- Coordinate release testing submission and data receipt
- Ensure suitable written records (i.e. batch analysis tables) and work undertaken are kept in accordance with cGMP and company procedures
- Manage QC test samples virtually at Contract Testing Labs
- Work closely with the QC Manager to track QC release, characterization, and stability data to communicate to cross functional and leadership audiences
- Assist with completing, sending and tracking sample submission forms and receiving data in accordance with Solid and Contract Testing Laboratory procedures and requirements.
Education, Experience & Skills:
- Minimum of an associate degree or equivalent in a scientific discipline• Minimum 1-2 years' experience in a cGMP laboratory, preferably related to pharmaceutical/biotechnology industry operations
- Good communication skills and be conversant in computer systems
- Excellent multi-tasking and organizational skills• Good understanding of relevant regulatory/industry standards and requirements
- Working knowledge of Veeva preferred• Ability and desire to work in a fast-paced, start-up environment
- Strong collaboration, team-working skills and communication skills• Independently motivated and detail-oriented with good problem-solving ability
No Travel Required