QC Sample Management Technician
Job Post Index
24E39E-Sy##
Location
Devens, MA
Description:
Description
- Responsible for the movement and control of QC samples and materials, including in-process, finished drug product, characterization, retain, and stability samples processed through the QC laboratories.
- This includes, but is not limited to, sample collection and distribution, inventory control, chain of custody, sample tracking, and sample delivery.
- Handle test samples throughout the sample life cycle: receipt, storage, distribution, transfer, and disposal.
- Facilitate cold chain transfers of samples.
- Ensure samples and materials are appropriately labelled and maintain sample tracking, labelling and chain of custody records in accordance with regulatory requirements and written procedures.
- Maintain inventory and distribution of QC samples and materials to functional groups as scheduled or requested.
- Record performance metrics for the sample management group.
- Support identification and implementation of process efficiencies.
- Communicate effectively with management regarding task completion, roadblocks, and needs.
- Working around biohazardous materials and may be exposed to fluctuating and/or extreme temperatures on occasion.
Skills:
Qualifications
- Associate’s degree in Chemistry, Microbiology or related science; OR
- High school diploma/GED with 2+ years of relevant work experience, preferably in a regulated environment.
- An equivalent combination of education and experience may substitute.
- Experience with cold chain sample storage and transfer in a GMP regulated environment is desirable.
- Knowledge of basic electronic systems (email, MS Office, etc.).
- Experience with LIMS and ELN computer applications preferred.
- Able to perform light to moderate lifting and carrying objects up to 20 lbs.
- Knowledge of regulatory standards as they apply to GMP laboratories is preferred.
- Attention to detail and demonstrated organizational skills.
- Ability to adapt and adjust to changing priorities and to manage assignments with challenging/conflicting deadlines.
- Ability to work in a high paced team environment and meet deadlines.
- Ability to communicate effectively with peers and department management.