Aseptic Manufacturing Associate

Kelly Science & Clinical is seeking an Aseptic Manufacturing Associate for a contract-to-hire position at a premier pharma company in Vacaville, CA. If you're passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.Pay Rate:$33-38/hourOverview:In this role, you'll be responsible for supporting all aspects of drug product manufacturing in a highly regulated, aseptic cleanroom environment, including routine documentation, equipment preparation, facility upkeep, and hands-on fill and finish production.Schedule:Primarily Monday-Friday, standard working hoursDuring production campaigns, there will be occasional early morning or late evening shifts required, with increased flexibility needed on certain days. Overtime is occasionally required.Responsibilities:Participate in the manufacturing of drug products, including placebo and media batches, while ensuring compliance with current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP).Maintain valid aseptic qualifications and consistently work inside high-classification (Grade A/B) cleanroom environments, with full aseptic gowning and adherence to stringent contamination control procedures.Prepare, operate, clean, and sterilize manufacturing and filling equipment, such as commercialized filling machines (e.g., Bosch fillers), and coordinate the transfer and setup of materials and components.Support project documentation by creating, updating, and reviewing standard operating procedures (SOPs), batch records, and protocols within the company's change management programs.Generate and investigate manufacturing deviations, participate in root cause analysis, and ensure timely deviation closure in accordance with company and regulatory deadlines.Collect in-process samples for Quality Control, perform regular inventory checks, complete facility fit-for-use documentation, and assist with facility cleaning as required, including back-up for the cleaning team when needed.Assist in the execution of process development and validation protocols and contribute to continuous improvement initiatives to enhance manufacturing quality and efficiency.Other duties as assigned.Qualifications:Bachelor's or Associate's degree in Science or related field required.6+ months of experience with aseptic gowning and filling/finishing experience.6+ months of cGMP experience.Strong communication, initiative, and flexibility in scheduling.