Job Listing Description

Associate Qa/Qc Technician

Description:
Chipton-Ross is seeking an Associate Qa/Qc Technician for an opening in Cambridge, MA.

SUMMARY:
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. Compiles data for documentation of test procedures and prepares reports. Provides QC support throughout Brammer Bio (e.g. projects, product transfers and regulatory inspections). Ensures all testing processes, monitoring, and departmental documentation meet Brammer Bio and cGMP regulatory standards.

RESPONSIBILITIES:
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.

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. 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.

EDUCATION:
Accredited BS or equivalent experience in clean room operations.

WORK HOURS:
Full-Time
 
Job Number: 187911
Job Location: Cambridge, MA
Rate: $DOE
Duration: 7 mos
Input Date: 11/14/2020
Firm Name: CHIPTON ROSS
Attention: Tyler Harrell
Address: 420 CULVER BLVD
City, State: PLAYA DEL REY, CA 90293
Phone: 310/414-7800 X286
800 Phone: 800/927-9318
Fax Phone: 310/414-7808
Email: tharrell@chiptonross.com
Website: www.chiptonross.com

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