Job Listing Description

Quality Control Specialist

Chipton-Ross is seeking a Quality Control Specialist for an opening in Alachua, FL.

The QC Specialist will work with a team of Scientists and analysts to technically review data, test records and reports generated during testing of GMP clinical lots, cell and viral banks as well as Process Development lots. The QC Specialist will communicate status updates on these activities to QC Management, Project Management, and QA to ensure that these activities meet project and production objectives on time.

The role will also support deviation investigations (OOS/OOT, etc) that occur within the QC laboratory. The QC Specialist will create, revise, edit, and prepare QC documents required for the functioning of the QC Analytical laboratory. This role will work cohesively with QC Management to ensure consistent delivery and execution of high-quality assay records and laboratory-related documentation.

Independently perform technical review of data, test records and reports generated during testing of GMP clinical lots, cell and viral banks as well as Process Development lots. Create and revise QC Standard Operating Procedures, Test Records, Stability and Assay Qualification Protocols and Reports to ensure compliance with the requirements of the QC Analytical laboratory and various regulatory agencies. Ensure Completion of Periodic/Biennial Review of documents. Support investigations (OOS/OOT, deviations, etc), CAPAs, Change Controls, and Planned Variances that occur within the QC laboratory. As needed, review results and deviations/ investigations from Contract Testing Laboratories (CTLs) as well as our in-house microbiology group. Other duties as assigned by supervisor.

One to three years of appropriate experience. College coursework may substitute at an equivalent rate for the required experience. Laboratory work experience in the fields of biotechnology, immunology, molecular biology, cell biology, or virology are required for this position. QA or QC experience in analytical testing and development is strongly recommended. Proficiency with Microsoft office programs such as Word, Excel, and PowerPoint. Excellent technical writing and oral communication skills are required. Previous experience with Laboratory Information Management Systems and other Electronic Document Systems (eg. Trackwise, Documentum, etc) is recommended. Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence. Ability to speak effectively before groups of customers or employees of organization. Ability to communicate/work in a high pressure/high paced environment. Ability to multi-task and function effectively as a member of a team.

Accredited Bachelorís degree in Life Sciences, Chemical/Biological Engineering, or an appropriate area of specialization.

M-F 8am-5pm
Job Number: 194046
Job Location: Alachua, FL
Rate: $25 to $26.00 DOE
Duration: 6 mos
Input Date: 09/14/2021
Attention: Dan Mulvihill
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

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