Quality Control Technician Jobs in Columbus, OH at Actalent
Title: Quality Control Technician
Location: Columbus, OH
Description:* -The individual will work primarily in the Quality Control Laboratory to support the testing and analysis of cGMP produced viral vectors and cells -Works in close collaboration with the QC manager and senior QC staff to cultivate and enact strategic direction to the GMP area -Sample assays that need to be run, and running same assays 5 nights a week most of the time -Perform the proper operation, calibration, validation, cleaning, and maintenance, of QC lab equipment -Under the guidance of senior staff, duties will include:
performance of QC methods, development of methods, analysis of microbiological environmental monitoring samples, writing/revising SOP’s, equipment maintenance and monitoring, and materials management of QC and Production supplies.
Additional tasks include periodic cleaning of clean room facility and periodic assistance with manufacturing of viral vector products. Operate within the Quality Management System applicable to the manufacture of phase appropriate material in the CMF. Ensure all product samples are adequately labelled and all aspects of sample allocation and transition are appropriately documented in the respective format and systems. Ensure full accountability for product as it is allocated across sample requirements and storage conditions. Evaluate processes associated with sample management to identify gaps and implement improvements.
Ensure documentation is completed, reviewed, filed and archived according to Standard Operating Procedures (SOPs). Maintain compliance with applicable regulatory requirements for cellular and gene therapy products. Performs in accordance with established policies, procedures, and techniques and requires training common experience or working knowledge related to the tasks performed Works under close supervision of staff and leadership. Functional working in diverse and collaborative team environment utilizing clear communication to deliver high productivity.
Documentation of all activities performed according to SOPs.
Skills:* Biology, virology,
QC, regulatory, clean room
Top Skills Details:* Biology, virology, Research, GMP, cGMP, GLP, QC, regulatory, clean room
Additional Skills & Qualifications:* -BS degree in Biology or other science field -Preferred experience includes:
aseptic technique, mammalian cell culture, PCR, and ELISA procedures -Highly Prefer experience from GMP manufacturing . -Looking for people that understand the regulatory and documentation constraints in a GMP environment.
Experience Level:* Entry Level
Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions. The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.