What are the responsibilities and job description for the QC Analytical Associate III position at Joulé?
Title : QC Analytical Associate III
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Location : Mahwah, NJ area
Schedule : Sunday to Thursday ( 6 : 00 am to 2 : 30 pm)
Type : Contract to Hire
Responsibilities :
The Quality Control Analytical Associate III serves as a support role to clinical and commercial production. The QC Analytical Associate III will assist with process check point, stability, and release analytical testing to ensure that quality standards are upheld for all products produced at the facility.
Under the direction of the Manager, QC Analytical, responsibilities of the QC Analytical Associate III will include but are not limited to : Performs accurate execution of all company and / or client test methods and procedures of cellular products to ensure the safety and / or efficacy of different cell populations
Performs maintenance, monitoring, and troubleshooting of pertinent equipment
Performs and assists in the training of other Quality Control Analytical Associates
Maintains training records and coordinates records retention with Document Control and Training groups
Tests, documents, and reports results for products or materials following company and / or client procedures following CGMP and / or GTP guidelines
Performs state proficiency testing and / or client proficiency testing under direct supervision as applicable
Participates in managing QC materials and supplies
Performs and assists in equipment and method qualification / validation activities as needed
Performs reagent and media preparation
Provides input based on level of knowledge and experience with troubleshooting malfunctioning equipment
Leads investigations for out-of-specification, out-of-trend, aberrant, and / or non-conforming test results
Determines root causes and implements intelligent corrective and preventive actions (CAPAs) and monitors CAPA effectiveness
Initiates, investigates, and prepares deviation reports with input from assigned supervisor
Brainstorms and implements corrective and preventive actions, as and when applicable
Documents training and execution of shipping test samples to contract laboratories for testing
Completes all documentation according to written Standard Operating Procedures in accordance to Current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP)
Ensures timely issuance, review, and approval of Certificate of Analysis, alongside timely closures of batch records, deviations, and CAPA
Initiates, assesses, approves, tracks, and trends deviations, Change Controls and CAPAs
Communicates effectively with other co-workers, departments, management and clients
Eventually serves as a lead and / or co-lead for client projects
Manages and drives resolution of quality issues with clients, collaborators, and internal personnel
Makes informed and independent decisions on complex issues in collaboration with key stakeholders and alignment with company policies.
Manages completion of document changes and maintains the internal QC change control system
Applies expertise of compliance requirements and therefore maintains an inspection-ready state laboratory
Participates as subject matter expert during audits / inspections
Works with internal departments and outside vendors, collaborators, and partners effectively for meeting projects timelines and commitments
Additional tasks as assigned
Requirements : BA / BS in a science or relevant field required
MS is preferred
Prior cGMP experience required
Prior QC laboratory, clinical laboratory, microbiology, hematology, blood banking, or immunology experience in a CGMP / GTP environment a must
GMP, Cell count, flow cytometry , documentation, flexibility, CBC, Endotoxin, ELISA, qPCR, Quality records (DRs, CAPA, CC, Docs revision) Fluency, multitasking, agility
Prior industrial experience in cell count methodologies preferred
Prior academic and / or industrial cell therapeutic experience preferred
Minimum 4-6 years of experience in Quality Control laboratory setting or within the biopharmaceutical industry
Proficient with computer software such as
Microsoft Office
Visio
Benefits
System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.
