Genezen is hiring a Remote Quality Assurance Specialist
\nPURPOSE\n\nBe an integral part of the Quality team by providing quality assurance oversight and leadership to operations, manufacturing, and quality control activities. Address terms of systems quality and conformance to regulations and Genezen quality policies/procedures. Help in the development of QA people and teams.\n\nESSENTIAL JOB FUNCTIONS / DUTIES\n\n\n* Assist in the maintenance of quality systems including a robust and continuous quality improvement system compliant with GMP and applicable to cell and gene therapy products used in early phase clinical trials.\n\n* Quality subject matter expert, providing training, oversight, collaboration and approval on all Quality Management Systems activities and outputs, including but not limited to electronic change control, quality events, deviation investigations and CAPAs in Veeva Vault QMS.\n\n* Develops and prepares quality management system metrics for Quality Management Review.\n\n* Provides support in the preparation, conduct, and follow-up activities associated with regulatory inspections and client audits\n\n* Quality review and approval of validation protocols, executed validation packages, and summary reports.\n\n* Quality partner on client tech transfer teams to successfully onboard new clients and new projects, including materials, suppliers, equipment, processes, master records, and additional support required.\n\n* Support internal and external (supplier) audit program as a qualified auditor, including writing audit reports and following up on corrective actions and commitments. \n\n\n\n\nSPECIAL JOB REQUIREMENTS\n\n\n* Adaptability required as work schedule may change based on business needs\n\n* Criminal background check and drug screen required\n\n* Other duties as assigned\n\n\n\n\nKNOWLEDGE, SKILLS & EXPERIENCE\n\n\n\n\n\nEDUCATION / CERTIFICATIONS / LICENSES\n\n\n\nEssential/Desired\n\n\n\n\n\nBachelorโs degree in science or related field\n\n\n\nEssential\n\n\n\n\n\nIn depth knowledge of cGMP FDA and EU regulations, and ICH guidelines\n\n\n\nEssential\n\n\n\n\n\nFamiliar with regulatory guidelines for early phase clinical trials\n\n\n\nEssential\n\n\n\n\n\nCertified Quality Auditor or Certified Pharmaceutical GMP Professional\n\n \n\n\n\nDesired\n\n\n\n\n\nON-THE-JOB EXPERIENCE\n\n\n\n \n\n\n\n\n\nMinimum of 3-5 years of working experience in Pharma, Biologics, CGT industry in a Quality Assurance role\n\n\n\nEssential\n\n\n\n\n\nPrevious experience reviewing and approving quality system reports โ deviation, CAPA, change control\n\n\n\nEssential\n\n\n\n\n\nPrevious experience reviewing validation protocols and reports\n\n\n\nDesired\n\n\n\n\n\nPrevious experience with product/process tech transfer\n\n\n\nDesired\n\n\n\n\n\nPrevious experience in the field of Gene Therapy\n\n\n\nDesired\n\n\n\n\n\nPrevious experience at a fast-paced CDMO.\n\n\n\nDesired\n\n\n\n\n\nSKILLS / ABILITIES\n\n\n\n \n\n\n\n\n\nManage multiple projects, set priorities, and work in fast-paced environment\n\n\n\nEssential\n\n\n\n\n\nCommunicate confidently and effectively with management, peers, and key stakeholders\n\n\n\nEssential\n\n\n\n\n\nDemonstrate effectiveness in task completion, decision-making, empowerment of others, and problem solving\n\n\n\nEssential\n\n\n\n\n\nPHYSICAL DEMANDS\nWhile performing the duties of this job, the employee is required to meet the following physical demands:\n\nWork Environment\n\n\n* Occasionally exposed to loud noise levels\n\n* Position can be a combination of remote and on-site\n\n* Regularly sit for long periods of time\n\n\n\n\nMovement\n\n\n* Frequently required to stand; sit; use hands to finger, handle, or feel; reach with hands and arms\n\n* Occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl\n\n\n\n\nLifting\n\n\n* Frequently lift and/or move up to 10 pounds\n\n* Occasionally lift and/or move up to 25 pounds\n\n\n\n\nVision\n\n\n* Frequently utilize close vision and the ability to adjust focus\n\n\n\n\nCommunication\n\n\n* Frequently required to communicate by talking, hearing, using telephone and e-mail\n\n\n
\n\n#Benefits\n
๐ฐ 401(k)\n\n๐ Distributed team\n\nโฐ Async\n\n๐ค Vision insurance\n\n๐ฆท Dental insurance\n\n๐ Medical insurance\n\n๐ Unlimited vacation\n\n๐ Paid time off\n\n๐ 4 day workweek\n\n๐ฐ 401k matching\n\n๐ Company retreats\n\n๐ฌ Coworking budget\n\n๐ Learning budget\n\n๐ช Free gym membership\n\n๐ง Mental wellness budget\n\n๐ฅ Home office budget\n\n๐ฅง Pay in crypto\n\n๐ฅธ Pseudonymous\n\n๐ฐ Profit sharing\n\n๐ฐ Equity compensation\n\nโฌ๏ธ No whiteboard interview\n\n๐ No monitoring system\n\n๐ซ No politics at work\n\n๐ We hire old (and young)\n\n
\n\n#Location\nIndianapolis, Indiana, United States
๐ Please reference you found the job on Remote OK, this helps us get more companies to post here, thanks!
When applying for jobs, you should NEVER have to pay to apply. You should also NEVER have to pay to buy equipment which they then pay you back for later. Also never pay for trainings you have to do. Those are scams! NEVER PAY FOR ANYTHING! Posts that link to pages with "how to work online" are also scams. Don't use them or pay for them. Also always verify you're actually talking to the company in the job post and not an imposter. A good idea is to check the domain name for the site/email and see if it's the actual company's main domain name. Scams in remote work are rampant, be careful! Read more to avoid scams. When clicking on the button to apply above, you will leave Remote OK and go to the job application page for that company outside this site. Remote OK accepts no liability or responsibility as a consequence of any reliance upon information on there (external sites) or here.