Job Summary:
Associate, QC Sample Management at the Cell Therapy Facility (CTF) in Devens, MA. Responsible for movement and control of QC samples/materials (in-process, finished drug product, characterization, retain, stability) including sample collection/distribution, inventory control, chain of custody, sample tracking, and sample delivery.
Responsibilities:
- Handle test samples: receipt, storage, distribution, transfer, disposal; facilitate cold chain transfers.
- Ensure proper labelling and maintain tracking, labelling, and chain-of-custody records per regulatory requirements and written procedures.
- Maintain inventory/distribution of QC samples/materials to functional groups.
- Maintain 5S and FIFO principles.
- Support performance metrics for the sample management group.
- Support investigations via data gathering or interviews.
- Collaborate to identify and implement process efficiencies.
- Communicate task status, roadblocks, and needs to management; perform other tasks as assigned.
Work Schedule:
6AMβ6PM on a 12-hour rotating shift (36/48 hours over 2 weeks); every other weekend, holidays on scheduled workdays, adverse weather; flexibility for irregular hours/short-notice overtime.
Qualifications (Required/Preferred):
- Cold chain sample storage/transfer experience in a GMP-regulated environment (required).
- Basic electronic systems (email, MS Office) (required).
- LIMS and ELN experience preferred.
- Light-to-moderate lifting up to 20 lbs.
- Regulatory standards knowledge as applied to GMP laboratories preferred.
- Attention to detail; organizational skills; adaptability; ability to manage multiple deadlines.
- Strong communication in team/cross-functional settings.
- Bachelorβs in Chemistry/Microbiology/related with 0β2+ years, or Associate with 2+ years (or equivalent).
- Exposure to biohazardous materials; potential extreme temperature exposure.
Benefits/Compensation (as listed):
- $32.18β$38.99/hour (Devens, MA, US).
- Health coverage (medical/pharmacy/dental/vision); wellbeing support; 401(k); short-/long-term disability; life insurance and other listed protection benefits.
- Paid time off options as described above.
Application Instructions:
None provided in the job description body.