Quality Sample Management Associate in Devens, MA

Work Schedule: Second Shift 2:00 PM - 10:00 PM. Monday through Friday.

Flex required as Holidays are required and weekend coverage as needed by Manufacturing Schedule.
Position Handles Hazardous Materials

Summary

• Performs routine processing and data review of raw materials, in-process, batch release, and/or stability samples of Bulk Drug Substance in a cGMP compliant environment.
• Performs routine inventory and sample management of routine samples, critical reagents and non-routine samples.
• Main responsibilities include Chain of Custody.
• Executes routine procedures owned by the Sample Management functional area.
• Assignments are made in the LMS, by the hiring manager, based on applicable curricula map(s).
• Knowledge of science generally attained through studies resulting in a AS or certificate program in the physical or life sciences, supply chain, a related discipline, or the equivalent in related experience.
• Knowledge of basic laboratory techniques such as working in a BSC, pipetting, aseptic technique; basic laboratory safety practices preferred.
• Familiarity with controlled temperature storage, sample inventory, and sample shipment and receipt.
• Attention to detail and demonstrated organizational skills.
• Demonstrated manual dexterity.

Duties:

• Will work in teams and have continual interaction with members of his/her team as well as other sub-teams within Quality Control Organization, in order to exchange information regarding sample management as it relates to meeting department goals and objectives
• Daily contact with her/his supervisory staff for work assignments. Routine contact with supervisor for coaching and general performance management discussions.
• Occasional contact with other line management staff relating to specific project responsibilities may be expected.
• Occasional contact with Manufacturing and Stability organizations for escalation where appropriate
• Occasional contact with other sites/vendors for tactical logistical purposes
• Associates primarily work in a cGMP laboratory and follow techniques which require one to be alert, giving a high attention to detail, to properly use Personal Protective Equipment (PPE) and to handle hazardous materials.
• Associates should be observant of their work area and related tools and identify and report any discrepancy from normal practice or procedure.
• Knowledge of basic electronic systems (email, MS Office, etc.)
• Attention to detail is key.

Education:

• HS Diploma required OR enrolled in a scientific program

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