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AMERICAN CYBERSYSTEMS INC. Quality Assurance Specialist in Seattle, Washington

Innova Solutions is immediately hiring for a Quality Assurance Specialist Position Type: Contract Duration: 12 Months Location: Summit, NJ (50% Onsite) As a Quality Assurance Specialist, you will: * Review executed batch records to ensure compliance with approved procedures and communicate and resolve discrepancies with manufacturing operators or supervisors. * Provide Quality support and guidance during GMP events and initiation of deviation investigations. * Review deviations, product non-conformities, and GMP investigations to ensure adequate resolution and compliance with current Good Manufacturing Practices (cGMPs).? * May own department events and minor deviations. * Support the batch disposition process by ensuring that all required documents are accurately and properly completed, including all batch related deviations. * Review and approve change control documentation that assesses and defines the scope, impact, risk, and regulatory impact associated with the change * Review, own, edit, and approve controlled documentation in accordance with cGMP standards * Coordinate and/or lead cross-functional meetings with multiple departments to drive change control implementation * May support internal and external audits, including documenting observations and implementation of corresponding CAPAs.? * Lead small scope projects as assigned. * Revise Standard operating Procedures as needed. * May train and mentor junior team members. The ideal candidate would possess: * Bachelor's degree in relevant science or engineering discipline is preferred. Minimum of Associates degree * 3-5 years of relevant cGMP experience. Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing is preferred. * Hands-on experience with batch record review and product disposition is preferred. * Strong computer skills with Word and Excel and other electronic manufacturing systems. 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! Mohit Vyas Sr. Associate ? Recruitment Mohit.Vyas@innovasolutions.com PAY RANGE AND BENEFITS: Pay Range*: $55-$61.23 per hour. *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: * One of Largest IT Consulting Staffing firms in the USA - Recognized as #4 by Staffing Industry Analysts (SIA 2022) * ClearlyRated® Client Diamond Award Winner (2020) * One of the Largest Certified MBE Companies in the NMSDC Network (2022) * Advanced Tier Services partner with AWS and Gold with MS Website:

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