QC Associate I
Job
Actalent
Allendale, NJ (In Person)
$63,440 Salary, Full-Time
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Job Description
Job Title:
Quality Control Associate I Job Description As a Quality Control Associate I, you will perform testing to develop methods for flow cytometry and analysis. You will engage in cell culture and cell counting to ensure quality control and help analyze flow methods and complexity testing. Your role will involve providing input to improve workflow and laboratory activity and offering training and oversight to new team members. Responsibilities Execute company and client test methods and procedures of cellular products to ensure safety and efficacy. Perform maintenance, monitoring, and troubleshooting of laboratory equipment. Test, document, and report results for products or materials following CGMP and GTP guidelines. Organize the lab and manage supplies efficiently. Perform cleanings of laboratory equipment as per SOP. Assist in equipment and method qualification/validation activities. Cross-train in methods for multiple clients to enhance lab efficiency. Upload data in real-time to shared drives or client SharePoint sites. Prepare reagents and media. Respond to equipment alarms using the Linc Alarm Report system. Troubleshoot malfunctioning equipment and provide insights based on experience. Investigate out-of-specification, out-of-trend, aberrant, and non-conforming test results. Initiate, investigate, and prepare deviation reports with supervisor input. Brainstorm and implement corrective and preventive actions. Document training and execute shipping test samples to contract laboratories. Complete all documentation according to SOPs in line with CGMP and GDP. Communicate effectively with coworkers, departments, management, and clients. Assist in training other Quality Control technicians. Essential Skills Flow cytometry and cell culture expertise. 1-2 years of experience in performing flow cytometry assays and endotoxin testing. 1-2 years of cell culture experience. Experience in quality control settings. Proficiency in clinical and commercial production support. Familiarity with process checkpoint, stability, and release analytical testing. Additional Skills & Qualifications Bachelor's or Master's degree in a related scientific field. Experience with microbiology test methods. Experience in training and leading others in the lab. Experience in aCGMP/GTP
environment is preferred. Prior industrial experience in cell count methodologies is preferred. 2-4 years of experience in a Quality Control laboratory setting or the biopharmaceutical industry. Proficiency with Microsoft Office and Visio. Work Environment This position operates on a Sun-Thurs second shift schedule from 2:30 PM to 11:00 PM. Initial training occurs Monday through Friday from 8:00 AM to 4:30 PM. Flexibility is required as work hours may vary. You will work within an aseptic quality environment, alongside scientists and other associates. The role involves electronic-based SOPs and paper-based testing and documentation. The company fosters a collaborative environment with opportunities for growth, project management, and leadership roles. Job Type & Location This is a Contract to Hire position based out of Allendale, NJ. Pay and Benefits The pay range for this position is $30.00 - $31.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:- Medical, dental & vision
- Critical Illness, Accident, and Hospital
- 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available
- Life Insurance (Voluntary Life & AD&D for the employee and dependents)
- Short and long-term disability
- Health Spending Account (HSA)
- Transportation benefits
- Employee Assistance Program
- Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Allendale,NJ.
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