QC Analyst II-Bioassay

Job Title:

QC Analyst II - Bioassay Job Summary The QC Analyst II - Bioassay is responsible for performing cell-based immunology and molecular biology assays in a regulated laboratory environment. This role supports quality control testing through study design, execution, data analysis, and documentation while ensuring full compliance with cGMP/GLP standards. The ideal candidate will have hands-on experience with mammalian cell culture, strong attention to detail, and the ability to maintain accurate and compliant laboratory records. Key Responsibilities Perform cell-based immunology assays including mixed lymphocyte reactions (MLR), cytotoxicity assays, HLA restriction assays, and cell proliferation assays using appropriate laboratory instrumentation. Design and execute QC studies, including defining assay conditions, controls, and sample handling procedures in accordance with established protocols. Analyze data and perform basic statistical evaluations to assess assay performance, variability, and trends. Document and report results clearly, including preparation of technical reports, summaries, and presentations. Accurately record test results, observations, and metadata into laboratory databases and trending systems. Maintain and handle mammalian cell cultures, including thawing, passaging, expanding, and preparing cells for assay use. Apply aseptic techniques to ensure integrity of cell-based assays and prevent contamination. Support daily QC lab operations including inventory management, reagent preparation, and maintenance of logs and documentation. Maintain clean, organized, and compliant laboratory workspaces through routine cleaning and sanitization procedures. Ensure adherence to cGMP/GLP regulations, SOPs, and good documentation practices (GDP). Review QC data and documentation for accuracy, completeness, and compliance. Support investigations related to out-of-specification (OOS) results and participate in CAPA activities. Identify opportunities for process improvements to enhance lab efficiency, quality, and consistency. Collaborate with cross-functional teams to meet project timelines and QC deliverables. Perform additional duties as assigned to support laboratory operations. Required Qualifications Bachelor's degree in Biology, Biochemistry, Microbiology, or a related scientific field. 1-2 years of relevant laboratory experience in biotechnology, pharmaceuticals, cell therapy, or a related industry. Hands-on experience with mammalian cell culture and aseptic techniques. Experience performing cell-based immunology assays. Working knowledge of cGMP and GLP regulations, including familiarity with 21 CFR 210/211. Strong documentation skills with a clear understanding of good documentation practices (GDP). Ability to analyze data and perform basic statistical evaluations. Strong attention to detail and organizational skills. Effective communication skills, both written and verbal. Preferred Qualifications Experience working in a QC or regulated laboratory environment. Familiarity with laboratory information management systems (LIMS) or trending tools. Experience supporting OOS investigations and CAPA processes. Exposure to SOP development or revision. Experience with cleaning validation, sterilization, and laboratory compliance practices. Work Environment This role operates within a regulated laboratory environment at a clinical research or biotechnology organization. The position requires routine work with mammalian cell cultures, bioassay systems, and laboratory instrumentation under strict cGMP/GLP guidelines. Candidates should be comfortable working in a structured, compliance-driven setting with a strong emphasis on data integrity, cleanliness, and procedural accuracy. Job Type & Location This is a Contract to Hire position based out of

MEMPHIS, TN.

Pay and Benefits The pay range for this position is $21.13 - $24.50/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

MEMPHIS,TN.

Application Deadline This position is anticipated to close on May 20, 2026. Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I is 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 Actalent is an equal opportunity employer. About Actalent Actalent is a global leader in engineering and sciences services. For more than 40 years, we've helped visionary companies advance their goals. Headquartered in the United States, our teams span 150 offices across North America, EMEA, and APAC—with four delivery centers in India led by 1,000+ extraordinary employees who connect their passion with purpose every day. Our Bangalore, Hyderabad, Pune, and Chennai delivery centers are hubs of engineering expertise, with core capabilities in mechanical and electrical engineering, systems and software, and manufacturing engineering. Our teams deliver work across multiple industries including transportation, consumer and industrial products, and life sciences. We serve more than 4,500 clients, including many Fortune 500 brands. Learn more about how we can work together at actalentservices.com.