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AMERICAN CYBERSYSTEMS INC. Specialist, QA Engineering in Warren, New Jersey
Innova Solutions is immediately hiring for a QA Engineering Specialist Position Type: Contract Duration: 12 Months Location: Warren, NJ As a QA Engineering Specialist, you will: * Functional responsibilities include ensuring accurate and timely maintenance of validation and qualification documents for all equipment and facility activities; investigations and evaluation of change control. * Ensure IT systems are designed, setup and function in a GMP-compliant manner to safeguard and maintain the safety and quality of client's products. * Provides QA oversight on key software development life cycle (SDLC) processes such as problem, incident, change, release and deviations. * Support the Qualification and Validation activities in relation to QC and manufacturing equipment and facility design. * Assures appropriateness of calibration/maintenance programs, validation plans, qualification protocols, associated reports and procedures. * Support ECQ, Facilities, QC and manufacturing equipment-related investigations in ensuring appropriate and thorough impact assessment, root cause analysis and corrective/preventive actions are documented and implemented. * Ensures compliance with the site validation master plan, assist with facility start-up operations and product transfers supporting the Qualification and Validation teams. * Work with Engineering/Facilities/ECQ management to ensure functional activities comply with global regulatory requirements. * Sponsor and support the change initiatives and the implementation of process improvement initiatives. * Ensure site is compliant with global and regulatory data governance and data integrity requirements. * Support any other goals and objectives of the site Quality Assurance organization, as needed The ideal candidate would possess: * B.S. degree required. * 8 + years of experience in the pharmaceutical or related industry required * Must have advanced knowledge and experience with GMP, Quality and compliance. * Previous experience as a computer system validation / quality assurance for life sciences company regulated by the FDA is preferred. * Advanced level experience in design of user requirement specifications, IQ/OQ/PQ protocols, user acceptance testing and other equipment/facility qualification documentation. * Must be fluent in standard Microsoft Office software; experience in asset management software (e.g. Blue Mountain RAM) and quality systems software (e.g. Veeva). * Drives use of best practices during IT systems design, validation, and use. * Must be able to critically review investigations and reports, interpret results, and generate technical conclusions consistent with Quality risk management principles. * Intermediate knowledge of quality systems including CAPA, change control, and document management 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*: $60-$65 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: https://www.innovasolutions.com/ Innova Solutions is an Equal Opportunity Employer and prohibits anyTo view the full job description, click here