What are the responsibilities and job description for the Quality Sample Management position at ECLARO?
Job Description : Quality Sample Management
Onsite role, Devens site
Work Schedule : Second Shift 2PM - 10PM. Monday through Friday.
Flex required as Holidays are required and weekend coverage as needed by Manufacturing Schedule.
- 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.
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
Additional Job Requirements :
Position Handles Hazardous Materials
