QA Engineering Specialist

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Job description

Innova Solutions is immediately hiring a QA Engineering Specialist

Job Title: QA Engineering Specialist
Position type: Full-time Contract
Duration: 12 Month
Location: Warren NJ
Pay range: $40 -$ 45.45 /Per Hour

As a QA Engineering Specialist, you will:
The Specialist, QA Engineering is responsible for ensuring quality, integrity, and compliance of site Information Technology (IT) systems, review of validation and qualification documents for all equipment and facility activities. This position is a member of the Cell Therapy Development and Operations (CTDO) organization, which supplies autologous and allogeneic cell therapies for first-in-human and pivotal clinical trials.

Required Competencies:

• Must have knowledge and experience with GMP, Quality and compliance.
• Previous experience as a computer system validation / quality assurance for life sciences company regulated by
  the FDA is preferred.
• Experience in design of user requirement specifications, IQ/OQ/PQ protocols, user acceptance testing and other
  equipment/facility qualification documentation.
• Must be fluent in standard Microsoft Office software; experience in asset management software (e.g. Blue
  Mountain RAM) and quality systems software (e.g. Veeva).
• Drives use of best practices during IT systems design, validation, and use.
• Must be able to recognize and group technical / scientific attributes and drive science-based decisions in most
  technical areas.
• Must manage development of technical or scientific initiatives and activities by interdisciplinary teams.
• Must be able to critically review investigations and reports, interpret results, and generate technical conclusions
  consistent with Quality risk management principles.
• Intermediate knowledge of quality systems including CAPA, change control, and document management systems.
• Requires minimal direction to complete tasks, authority to make daily decisions that impact their team.
• Negotiates solutions cross-functionally. Drives continuous improvement and improves efficiency and
  productivity within the group or project.
  
  Duties And Responsibilities
• Functional responsibilities include ensuring accurate and timely maintenance of validation and qualification
  documents for all equipment and facility activities; investigations and evaluation of change control.
• Ensure IT systems are designed, setup and function in a GMP-compliant manner to safeguard and maintain the
  safety and quality of Client products.
• Provides QA oversight on key software development life cycle (SDLC) processes such as problem, incident,
  change, release and deviations.
• Support the Qualification and Validation activities in relation to QC and manufacturing equipment and facility
  design.
• Assures appropriateness of calibration/maintenance programs, validation plans, qualification protocols,
  associated reports and procedures.
• Support ECQ, Facilities, QC and manufacturing equipment-related investigations in ensuring appropriate and
  thorough impact assessment, root cause analysis and corrective/preventive actions are documented and
  implemented.
• Ensures compliance with the site validation master plan, assist with facility start-up operations and product
  transfers supporting the Qualification and Validation teams.
• Work with Engineering/Facilities/ECQ management to ensure functional activities comply with global regulatory
  requirements.
• Sponsor and support the change initiatives and the implementation of process improvement initiatives.
• Ensure site is compliant with global and regulatory data governance and data integrity requirements.
• Support any other goals and objectives of the site Quality Assurance organization, as needed
  
  Education And Experience
• B.S. degree required.
• 1 - 3 years of experience in the pharmaceutical or related industry.
  
  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
  
  
  PAY RANGE AND BENEFITS:
  Pay range: $40 -$ 45.45 /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:
  One of Largest IT Consulting Staffing firms in the USA - Recognized as 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:
  
  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.

American Cybersystems, Inc is acting as an Employment Business in relation to this vacancy.

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