Innova Solutions has a client that is immediately hiring for a QA Engineering Specialist Position type: Full-time, Contract Duration: 08 months Location: Warren NJ Onsite As a QA Engineering Specialist, you will: Responsible for providing quality oversight on technology transfer into and out of the site, process understanding and enhancement, and other site qualification activities in a fast-paced, highly collaborative manufacturing facility. This team supports the Cell Therapy Development early clinical drug product manufacturing facility, which supplies autologous and allogeneic cell therapies for first-in-human and pivotal clinical trials. Duties/Responsibilities : QA lead on technology transfer activities (process): Ensure technology transfers on new product introduction and/or new trials and cohorts are compliant with internal standards and/or regulatory requirements, as applicable. Maintain knowledge of scientific literature, regulatory guidelines, internal standards/procedures and apply key concepts during project activities/plans. Interact and coordinate with other QA functional teams to ensure timely completion of QA related activities. Interact and collaborate with cross-functional teams to achieve common goals Provide training to QA colleagues on new product manufacturing process, as applicable to ensure clinical production readiness. Must be knowledgeable on change control process. Must be knowledgeable on the process and associated methods for the assigned product. Support Product/Program Lifecycle Management Activities Support change initiatives and implementation of new technologies, process and method improvements, material changes and ensure compliance with internal standards and regulatory requirements. Support regulatory filings and amendments, as applicable (i.e. IND, INDa, CTA etc.) Participate and drive Quality Risk Management (QRM) initiatives at the site to ensure risk areas are identified and risk control measures are implemented. Review media simulation activities to ensure successful execution and documentation. Maintain data integrity by ensuring procedures/processes are compliant with internal data integrity standards and procedures. Work with Engineering/Facilities/Warehouse/Supply Chain/Manufacturing Operations/Quality Control management to ensure functional activities comply with internal standards and regulatory requirements. EDUCATION AND EXPERIENCE B.S. degree required. Minimum of six years of experience in the pharmaceutical or related industry. Equivalent combination of education and experience acceptable. REQUIRED COMPETENCIES Must have strong understanding of global cGMP, quality systems (especially change management), and guidance documents. Must have knowledge of technology transfer for manufacturing processes. Must have strong authorship and be able to critically review investigations and reports, interpret results, and generate technical conclusions consistent with quality risk management principles. Must have strong quality background. Qualified candidates should APPLY NOW for immediate consideration! Please hit APPLY to provide the required information, and we will be back in touch as soon as possible. We are currently interviewing to fill this and other similar positions. If this role is not a fit for you, we do offer a referral bonus program for referrals that we successfully place with our clients, subject to program guidelines. ASK ME HOW. Thank you! Sara Almas Sara.Almas@innovasolutions.com PAY RANGE AND BENEFITS: Pay Range: $60- $64.00 /hr. Pay range offered to a successful candidate will be based on several factors, including the candidate's education, work experience, work location, specific job duties, certifications, etc. Benefits: Innova Solutions offers benefits( based on eligibility) that include the following: Medical & pharmacy coverage, Dental/vision insurance, 401(k), Health saving account (HSA) and Flexible spending account (FSA), Life Insurance, Pet Insurance, Short term and Long term Disability, Accident & Critical illness coverage, Pre-paid legal & ID theft protection, Sick time, and other types of paid leaves (as required by law), Employee Assistance Program (EAP). ABOUT INNOVA SOLUTIONS: Founded in 1998 and headquartered in Atlanta, Georgia, Innova Solutions employs approximately 50,000 professionals worldwide and reports an annual revenue approaching $3 Billion. Through our global delivery centers across North America, Asia, and Europe, we deliver strategic technology and business transformation solutions to our clients, enabling them to operate as leaders within their fields. Recent Recognitions: * Named One of America's Best Employers for New Grads by Forbes (2024 * NaTo view the full job description, click here