QC Sample Management Technician I in Devens, MA

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The QC Sample Management Technician I is 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.

This role works a 12-hour rotating shift (36/48 hours over a 2-week period) which includes working every other weekend, holidays falling on scheduled workdays, and during adverse weather conditions in support of QC and the manufacturing facility. Flexibility to work irregular hours and short notice overtime may be required.

Shifts Available:

Day Shift: 6am – 6pm, rotating schedule including holidays and weekends, onsite

Night Shift: 6pm – 6am, rotating schedule including holidays and weekends, onsite

Responsibilities:

• Handle test samples throughout the sample lifecycle: 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.

Knowledge and Skills:

• 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.

Basic Requirements:

• Associate’s degree in Chemistry, Microbiology or related science; or a 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.

Working Conditions:

• The incumbent will be working around and handling biohazardous materials and may be exposed to fluctuating and/or extreme temperatures on occasion.

This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are inten