Quality Records Specialist

Innova Solutions has a client that is immediately hiring for a Quality Records Specialist Position type: Contract Duration: 12 months Location: Summit, NJ (onsite) As a Quality Records Specialist you will: Job Description: * The Global Supplier Quality, External QC -Vector will process external deviation and change records from our Contract Test Laboratories (CTL). * Coordinate testing of samples for lot release, PPQ, PSQ and will compile vendor documentation to generate a CoA/CoT. * This role will partner cross functionally with Global Product Quality, External Manufacturing Supply Chain, and Global Supplier Quality to release vector in a timely manner for commercial, clinical and early development programs. * Initiation, facilitation, and tracking of quality records * Provide regular communication and metrics for status of quality records * Effectively communicate issues, risks and proposed solutions within the organization * Provide communication, support, and guidance to CTLs within the QA vector and upstream material team * Create and revise SOP * Create and revise Certificates of Analysis (CoA) and Certificates of Testing (CoT) * Enter data and retrieve information from SharePoint and Smartsheet testing trackers The ideal candidate will have: * Preferred Bachelors in relevant scientific discipline, or 3 years' experience in biotherapeutics/biomanufacturing QC/QA. * Experience with deviation and change control management, preferably with Infinity systems * Advanced project management skills such as process excellence/six sigma methods and approaches including process mapping, root cause analysis and problem definition * Experience within the Cellular Therapeutics and/or gene-based products. Experience with biologics will be considered. * Experience with Clinical and/or Commercial products manufacture, supply and post-approval change management * Knowledge of applicable FDA/EMA regulations in the biotechnology industry * Experience managing external suppliers and other supply chain issues * Experience with Quality Systems (change control, deviation and investigation) 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! Aritra Roy PAY RANGE AND BENEFITS: Pay Range*: $30 - $31 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: * Named One of America's Best Employers for New Grads by Forbes (2024 * Named One of the Best Companies to Work For by U.S. News & World Report (Private Companies List, ) * One of the Largest IT Staffing Firms in the US - Ranked #3 by Staffing Industry Analysts (SIA, 2024) * One of the Largest Staffing Firms in the US - Ranked #13 by Staffing Industry Analysts (SIA, 2024; includes Innova Solutions, Volt, & HireGenics) * Named One of the Top Ten Private Companies in Atlanta by the Atlanta Business Chronicle (2023) * One of the Largest Certified Minority Business Enterprises (MBEs) in the United States (NMSDC, 2024) * AWS Advanced Tier Services Partner with 100+ certifications Website: Innova Solutions is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. Innova Solutions is committed to the principle of equal employment opportunity To view the full job description, click here>

Created: 2024-11-02