QC Associate I, II & III job in Allendale
|Employer:|| Hitachi Chemicals Advanced Therapeutic Solutions|
|Job Type:||Full Time|
|State:||New Jersey (NJ)|
Allendale, NJ 07401, USA (Show on map)
We are seeking highly motivated QC Associates I, II & III who are interested in joining our fast-paced, dynamic environment.
These positions performs daily Quality Control activities under the direction and guidance of the supervisor/ manager in support of HCATS and client procedures. The ideal candidates must be proficient in QC test methods and procedures and use of the QC laboratory equipment.
The QC Associate will ensure that all procedures are performed with precision and accuracy and with clear and accurate documentation. The individuals in these positions must be complaint with all applicable SOPs and good documentation practices as well as CGMP and GTP requirements. These positions are based in Allendale, NJ.
Performs the accurate execution of any and all HCATS and/or client test methods and procedures of cellular products to ensure the Safety and/or Efficacy of different cell populations
Perform maintenance, monitoring, and trouble-shooting of pertinent equipment
Test, document and report results for products or materials for Clinical Trial supplies following HCATS or client procedures and CGMP & GTP
Successfully, perform state proficiency testing and/or client proficiency testing under direct supervision as applicable
Participate in managing QC materials and supplies ; Ordering of materials; Manage and monitor the use of materials
Perform and assist in equipment and method validations as needed; Reagent and Media Preparation
Able to provide input based on level of knowledge and experience to trouble shoot equipment malfunctions and investigate out of specification and/or non-conforming test results
Initiate, investigate and prepare deviation reports with input from supervisor in a timely manner and implement corrective actions, preventive actions
Communicate effectively with other co-workers, departments, management and clients.
Additional tasks as assigned by the Quality Assurance Management
Education and Experience:
Bachelor’s Degree in a relevant field required
Medical Technologist license or equivalent preferred
MUST have 1-5 years applicable or related experience in a clinical laboratory, hematology, blood banking, immunology or QC laboratory preferably in a CGMP/GTP environment
MUST have a minimum of 2-5 years of QC related experience in the pharmaceutical or biologics industry
Flow Cytometry experience is preferred
MUST be able to work a flexible shift, as required
Strong team-oriented, interpersonal skills are essential
Must be able to manage and coordinate all tasks assigned and effectively deliver all expected deliverables in a timely manner and proactively communicate changes in pre-established goals and deadlines
Excellent organizational skills and attention to detail
Good verbal and written communication skills
Hitachi Chemical Advanced Therapeutics Solutions, LLC (formerly PCT Cell Therapy Services, LLC), is an industry leader in contract development and manufacture of cell therapy products. HCATS works with its clients to overcome the fundamental challenges of cell therapy manufacturing by providing a wide range of innovative services including product and process development, full scale cGMP/GLP manufacturing, engineering and automation, cell and tissue processing, logistics, storage and distribution, as well as expert consulting and regulatory support.
Our mission is to provide our clients with high quality, scalable, innovative, reliable, and cost efficient manufacturing platforms and services to advance commercialization of cellular therapies. We are in the business of developing innovative service products for cell therapy manufacture; selling these to senior leaders in charge of development programs in collaboration with their subject matter experts; and delivering these service products for the development and execution of cell-based therapy manufacturing directly to clinical and commercial development teams around the world.
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