Specialist, QA Engineering

4 weeks ago

Warren, United States American Cybersystems Full time

Innova Solutions has a client that is immediately hiring for a Quality Assurance Engineering Specialist, Position type: Full-time Contract Duration: 12 months Location: Warren, NJ As a Quality Assurance Engineering Specialist, you will: The Senior Specialist is responsible for supporting the Quality Engineering group from a Subject Matter Expert (SME) standpoint in accordance with Client policies, standards, procedures, and Global cGMP. Functional responsibilities for the incumbent include facilitating Change Control Review Board (CCRB) and record tracking meetings (e.g. Change Actions weekly) as applicable, driving proactive and corrective improvements within Operations, providing support at all regulatory inspections and corporate audits, tracking internal/external audit commitments and driving on time closure, evaluation of new requirements and emerging regulations, providing user support for the different Quality Systems as a site lead which includes integration activities and generation and review of Site Quality Metrics. Responsibilities: * Ensure control of systems, processes and products through facilitation of CCRB. Represent site and provide impact assessment for global changes at Global CCRB Monitor and track external audit/inspection commitments to ensure timely closure. Track site change controls and ensure appropriate requirements are identified and completed for implementation. Provide weekly change control due date updates to the Tier board metrices. Must be skilled in planning and organizing, decision-making, and building relationships. Familiar with Veeva Vault QMS system. Able to effectively multi-task. Reporting Relationship Reports to Senior Manager, QA Engineering Education And Experience * B.S. degree required, minimum of five years of experience in the pharmaceutical or related industry. * Experience with cGMP manufacturing, Quality, and compliance. * Thorough knowledge of and competence in quality processes, including material disposition, change control, product complaints, deviations, investigations, and CAPA management. Required Competencies * Must have advanced knowledge and experience with cGMP manufacturing, Quality, and compliance. * Directs quality initiatives that accomplish continuous improvement and enhance site manufacturing efficiencies, while providing a safe and compliant process. * Effectively prepare communications with interpretation of data analysis and potential problems to management and the group with clarity and a high level of accuracy. * Technical/scientific attributes in potential situations or issues and process science-based solutions across a majority of the job function. * Provide guidance to other employees in the interpretation of technical/scientific issues across a majority of the job function and manage development of technical or scientific initiatives and activities by interdisciplinary teams. * Knowledge of US and global cGMP requirements. * Understanding of aseptic manufacturing processes. 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 Team Recruitment Sara.Almas@innovasolutions.com PAY RANGE AND BENEFITS: Pay Range*: Between $55.00- $64.00 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 GraTo view the full job description, click here>

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