Job Listing Description

Clean Room Analyst

This ideal candidate will:
• Act as a team member of the Quality Control department to support routine environmental monitoring of air, surface, and clean utilities for manufacturing of in-process and final product drug lots for customers.
• Compile data for documentation of test procedures and prepare reports.
• Provide QC support throughout (e.g. projects, product transfers and regulatory inspections).
• Ensure all testing processes, monitoring, and departmental documentation meet Client and cGMP regulatory standards.

The Analyst will perform analysis of environmental monitoring test results according to Standard Operating Procedures (SOPs) and Test Methods and provides on-time, high quality results to meet Manufacturing demands.
• Routine environmental monitoring of air, surface, water, gas and steam systems
• Ensures that all work is in compliance with the required regulatory standards, conforms to company policies and standard operating procedures (SOPs).
• General lab support including housekeeping, equipment maintenance, inventory of supplies, etc
• Problem solving of analytical methods as well as troubleshooting of equipment will also be performed as the employee advances from one level to the next.
• Perform routine testing with supervisor direction
• Perform assay review achieved with assay competency with supervisor direction
• Provides frequent feedback to supervisor/manager.

Requires BS or equivalent experience in clean room operations.

Special Requirements
• Ability to gown and gain access to cleanroom areas
• Ability to work with Spor-Klenz
• Position is considered essential personnel and may be required to staff the lab during inclement weather or other internal/external emergency situations
• Occasional off shift or weekend hours may be required to meet business needs

At least 0-2 years of related experience or equivalent combination of education & experience.

Knowledge, Skills, Abilities
• Ability to communicate at all levels and across various functions
• Must have the ability to work in a fast paced, high workload environment, and be able to manage multiple projects and objectives for on-time event closure.
• Completes tasks where judgment is required in resolving problems and recommendations.
• Frequent use & general knowledge of industry practices, techniques and standards.
• Strong interpersonal and communications skills; written and oral.
• Understanding of applicable regulatory requirements.
• Must work well on a team and be able to trouble shoot and problem solve in a cross functional team setting.
• Must be proactive, action oriented and have the ability to adapt to a change.
• Experience with electronic systems such as LIMS, Trackwise, etc., is an advantage.
Job Number: 2010120540
Job Location: Cambridge, MA
Per Diem: split
Overtime: possible
Duration: 1 year
Start Date: ASAP
Input Date: 11/14/2020
Attention: Stephanie Spolzino
Address: 50 FOUNDERS PLAZA STE 304
City, State: EAST HARTFORD, CT 06108
Phone: 860/289-2643
800 Phone: 866/636-4723
Fax Phone: 800/556-5284

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