- Perform initial and routine validation activities for GxP computerized systems.
- Primary responsibilities include qualification of laboratory instruments, setup of computers and instruments, troubleshooting of system related issues, and technical writing and execution.
- Executes validation projects, system qualification, and implements industry best practices for the design and delivery of GxP computerized systems.
- Performs validation document generation, program management, and protocol execution activities.
- Interface with Engineering, and end user groups to support development of life cycle documents and system requirements.
- Design the validation approach with technical oversight, provide the scientific rationale and acceptance criteria, and generate validation protocols.
- Execute validation studies, perform data analysis, and write protocol summaries, reports, and technical reports.
- Protocol execution and project activities.
- Execute qualification activities with oversight.
- Participate in department and site project teams.
- Perform qualification activities according to site objectives and timelines.
- Edit department SOPs and generate basic revisions as required.
- Execute CAPA plans, risk assessments, investigations, and root cause analysis.
- Working understanding of site quality GxP systems supporting document management, change controls, deviations, CAPAs.
- Defend validation protocols in internal and external audits as a subject matter expert with limited supervision.
- Interact and collaborate with departments (on and offsite) as well as vendors, consultants, and other external service providers. Performs general administrative and organizational activities.
- Management of time and work deliverables, regular interface and reporting to management.
- Complete regulatory, site, and department training requirements on a timely basis.
The ideal candidate will have: - 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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Validation Specialist - Warren, United States - MassGenics
Description
Innova Solutions is immediately hiring for a Validation SpecialistPosition Type: Contract
Duration- 06 Months
Location- Warren, NJ
As a Validation Specialist, you will:
• Bachelor's degree preferred, preferably in Science or Engineering.
• 8 years relevant work experience required.
• An equivalent combination of education, experience and training may substitute.
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
PAY RANGE AND BENEFITS:
Pay Range*: $55-$61.93 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:
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 a reasonable accommodation to assist with your job search or application for employment, please contact us at or 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.
