Information Technology Quality Assurance

Innova Solutions has a client that is immediately hiring for an IT Quality Assurance Associate III

Position type: Fulltime/Contract

Location: Plainsboro, NJ

Duration: 12 Months

Hybrid Role ( 3 Days Onsite, 2 Days Remote)

As an IT Quality Assurance Associate III, you will:

TOP SKILLS:

* Strong knowledge of regulatory guidelines and standards related to computer system validation in the pharmaceutical industry (e.g., FDA 21 CFR Part 11, GAMP 5).

* Experience in validating computerized systems used in pharmaceutical industry.

* Knowledge of validation methodologies, risk assessment techniques, and validation documentation practices

In the position of IT Quality Assurance Associate, you will support implementation and operational aspects of IT systems while ensuring compliance with internal and external requirements.

PRIMARY JOB RESPONSIBILITIES:

• Provide compliance guidance across IT and stakeholders, focusing on computerized system validation (CSV) in a GxP regulated environment.

• Lead and oversee the validation and qualification processes for GxP computerized systems and infrastructure, both on-premises and cloud-based, to ensure adherence to 21CFR Part 11 Compliance and other relevant regulations.

• Review, and approve CSV lifecycle documents, including validation plans, requirements, risk assessments, and validation summary reports.

• Evaluate new computerized systems or software for GxP impact and provide risk-based validation guidance.

• Review incidents and changes to computer systems for GxP impact, identifying necessary validation or qualification requirements.

QUALIFICATIONS:

• Education requirement, minimum: Bachelor’s degree in computer science, Information Technology, Life Sciences, or a related field

• Experience requirement, minimum: minimum of 4 years of direct experience in validation in pharmaceutical, biotechnology, or regulated healthcare industry

• Proven experience in IT compliance and validation within a GxP regulated environment, specifically with 21CFR Part 11 compliance.

• Strong understanding of computerized system validation principles, regulatory requirements, and quality management systems.

• Excellent project management skills, with the ability to lead cross-functional teams and manage multiple projects simultaneously.

• Exceptional communication and interpersonal skills, with the capacity to work collaboratively with internal and external stakeholders.

• Detail-oriented with a strong analytical mindset and problem-solving capabilities.

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!

Ashutosh Bhadoria

Sr. Associate – Recruitment

Bhadoria.ashutosh@innovasolutions.com

( 1) 678-310-1263

PAY RANGE AND BENEFITS:

Pay Range*: $55.00- $60.00 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 Grads by Forbes 2024
• Named One of the Best Companies to Work for by U.S. News & World Report (Private Companies List, 2024-2025)
• 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: https://www.innovasolutions.com/

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 for all employees and to providing employees with a work environment free of discrimination and harassment on the basis of race, color, religion or belief, national origin, citizenship, social or ethnic origin, sex, age, physical or mental disability, veteran status, marital status, domestic partner status, sexual orientation, or any other status protected by the statutes, rules, and regulations in the locations where it operates. If you are an individual with a disability and need reasonable accommodation to assist with your job search or application for employment, please contact us at hr@innovasolutions.com or (770) 493-5588. Please indicate the specifics of the assistance needed. Innova Solutions encourages all interested and qualified candidates to apply for employment opportunities. Innova Solutions (HireGenics/Volt) does not discriminate against applicants based on citizenship status, immigration status, or national origin, in accordance with 8 U.S.C. § 1324b.

The company will consider for employment qualified applicants with arrest and conviction records in a manner that complies with the San Francisco Fair Chance Ordinance, the Los Angeles Fair Chance Initiative for Hiring Ordinance, and other applicable laws.