Description:

Ideal Candidate: 8-10 YOE would be ideal. Candidates should be experienced in managing GMP Samples, Aliquoting Samples, Picking up Samples in Manufacturing, Shipping/Receiving GMP samples, and Stability Sample management

Job Details: Under general supervision, this position will perform tasks associated with establishing routine procedures, and defining business process in support of the QC Sample management group.

This position will be responsible for one or more of the following activities, but not limited to:

1. Assist with procurement activities for consumables and critical reagents for lab start up.

2. Support the startup and qualification/validation of the Sample Management and Stability Laboratories in a GMP environment.

3. Assist with establishing the processes and procedures for sample handling and storage.

4. Develop/Perform routine Sample Management laboratory procedures:

- Sample Manufacturing Sweeps

- Aliquot cGMP samples

- Manage Sample Shipments

- Contract Testing Laboratory (CTL) Management

- Maintaining and operating specialized equipment as applicable

- Initiating and / or implementing changes in controlled documents.

- Support routine activities over the weekends and public holidays as required.

Ideal candidate must be familiar with documenting tasks within LIMS.

Must learn and comply with safety guidelines and cGMPs/CFRs which includes, but is not limited to, the maintenance of training records, laboratory documentation, written procedures, building monitoring systems and laboratory log books (as applicable).

Skills: Sample Management lab experience is required.