IT Quality Compliance Specialist/Analyst
American Cybersystems, Inc.
New Brunswick, New Jersey
$78.57 - $79.71 per hour
This job has expired.
Innova Solutions is immediately hiring for an IT Quality Compliance Specialist/Analyst
Tittle- IT Quality Compliance Specialist/Analyst
Duration -6 months
Location-New Brunswick ,NJ (onsite)
Pay Range*: $78.57 - $79.71 per hour.
As a(n)IT Quality Compliance Specialist/Analyst. you will:
Job Description:
- Manage and coordinate activities associated with the GxP IT Quality Assurance (QA) program for GPS and R&D computerized systems regulatory compliance across the end-to-end product lifecycle (GPS and R&D) for software development and validation lifecycle activities associated with regulated computerized systems to ensure conformance to cGxPs, guidance documents, applicable industry accepted standards and requirements.
- Carries out functions of the GxP-ITQA as directed including but not limited to:
- Review and approval of key computer system Validation Life Cycle (VLC) deliverables;
- Review and approval of test scripts and defects associated with computer system validation;
- Oversight of key Software Development Life Cycle (SDLC) process such as incident, problem, change, release, etc.;
- Ensure adequate and timely regulatory compliance support.
- Partner with IT Validation to ensure risk assessments, incident management and oversight are aligned to corporate and data protection standards.
- Provide backup support for the department as needed and perform other assignments as required.
- Support internal and external (regulatory) inspection activities related to validated systems.
- Provide support to assigned Quality programs, such as Data Integrity Governance, Investigations, Global Quality Headquarters Training and other, as assigned.
- Ability to manage multiple projects, create and work within internal timeliness, solve problems, deliver on commitments, and utilize interpersonal skills in a cross-functional team.
- Operate effectively and with minimal supervision, within a team or independently, performing special projects and related duties, as assigned.
- Bachelor's degree in a related field from an accredited college or university, with a minimum of 8 years of related experience.
- Experience in working in a GXP regulated industry and preferably in a quality assurance role
- Highly knowledgeable in Software Lifecycle Development (SDLC) and in review/approval of key computer system validation deliverables
- *Experience in providing quality oversight of software development quality systems such as problem, incident, change,release, deviations, periodic reviews
- Experience in validation of computerized software and related IT controls
- Familiar with validation testing activities and managing defects
- Knowledgeable in 21 CFR Part 11, Annex 11, GAMP and health authority regulations for computerized systems as well as worldwide pharmacovigilance regulations
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
4702230481
Aritra.Roy@innovasolutions.com
PAY RANGE AND BENEFITS:
Pay Range*: $78.57 - $79.71 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:
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 a 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.
This job has expired.
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