Quality Control Scientist I Job Description The individual will work primarily in the Quality Department to support the testing and analysis of cGMP produced viral vectors and cells. This role involves close collaboration with the QC manager and S r. QC staff to cultivate and enact strategic direction in the GMP area. Under the guidance of S r. staff, duties will include the performance of QC methods, development of methods, analysis of microbiological environmental monitoring samples, writing/revising SOPs, equipment maintenance and monitoring, and materials management of QC and Production supplies. There is one opening on the first shift (M-F, 8 AM to 4:30 PM, flexible) and one opening on the second shift (M-F, 2 PM to 10:30 PM, flexible) Responsibilities + Perform QC methods and develop new methods. + Analyze microbiological environmental monitoring samples. + Write and revise Standard Operating Procedures (SOPs). + Maintain and monitor equipment. + Manage materials for QC and Production supplies. + Conduct lab testing including PCR, qPCR, ddPCR, Gel Electrophoresis, and pH measurements. + Operate within the Quality Management System for phase-appropriate material manufacture in the CMF. + Ensure all product samples are adequately labeled and documented. + Ensure full accountability for product allocation across sample requirements and storage conditions. + Evaluate processes associated with sample management to identify gaps and implement improvements. + Complete, review, file, and archive documentation according to SOPs. + Maintain compliance with regulatory requirements for cellular and gene therapy products. + Perform tasks according to established policies, procedures, and techniques. + Work under close supervision of S r. staff and leadership. + Function effectively in a diverse and collaborative team environment with clear communication. Essential Skills + BS degree in Biology or other science field + 6+ months of industry quality experience + Experience with PCR, qPCR, ddPCR, Gel Electrophoresis, and pH measurements + Understanding of regulatory and documentation constraints in a GMP environment + Experience in report writing and documentation review Additional Skills & Qualifications + Prior GMP experience highly preferred + Experience from GMP manufacturing is highly preferred Work Environment This is a very team-oriented environment where team members work closely with one another. The team size is 10-12 on each shift, and the dress code is business casual. There is one opening on the first shift (M-F, 8 AM to 4:30 PM, flexible) and one opening on the second shift (M-F, 2 PM to 10:30 PM, flexible) Pay and Benefits The pay range for this position is $24.00 - $24.00 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 Columbus,OH. Application Deadline This position will be accepting applications until Dec 26, 2024. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through: + Hiring diverse talent + Maintaining an inclusive environment through persistent self-reflection + Building a culture of care, engagement, and recognition with clear outcomes + Ensuring growth opportunities for our people The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.