QA Associate Specialist - Document Control from Innova Solutions

Innova Solutions is immediately hiring for a QA Associate Specialist - Document Control

Position type: Full-time Contract
Duration: 12 Months
Location: Summit, NJ 07901 (Onsite)

As a QA Associate Specialist - Document Control, you will:
The Quality Assurance Document Control (QADC) Associate Specialist supports the cGMP Document Control operations for the Cell Therapy Above-site organization, including the document approvals, document change control process, periodic review and system reporting.

Primary responsibilities include:

• Managing an electronic document system for the Cell Therapy Above-Site which includes reviewing and approving document change requests, troubleshooting and releasing documents to an effective state.
• May write and revise document control procedures including participating in the development and roll-out of document control tools.
• Follow Policies, SOPs, and work instructions to support the document approval process, assign effective dates and training workflows, and archive documents and document change requests.
• Assist with cross-training of Document Control personnel and customers to ensure adherence with procedures.
• Execute the process and procedures for identifying, collecting, distributing and filing the controlled documents for the site.
• Generate document management system reports for Quality Council metric reporting.
• Support internal and external audits and regulatory inspections if required. Assist with document retrieval /organization support during regulatory inspections.
• Provide communication as to the status of Quality Systems deliverables to customers, management, and stakeholders.
• Some technical writing skill set and be able to critically review documents while effectively inputting and expressing Quality principles
  
  Education:
  • Bachelor's degree or equivalent
  
  Ideal candidate must have:
  2+ years of Document Control & Reporting Experience,
  Veeva experience preferred.
  Technical troubleshooting
  Experience working cross-functionally.
  
  Experience Basic Qualifications:
• Minimum of 1 year of relevant document control experience in a cGMP/FDA regulated environment.
• Some technical writing skill set including the ability to critically review documents while effectively inputting and expressing Quality principles.
• Strong computer skills with MS Office (e.g. Word, Adobe, Visio and Excel) and with Quality Systems (e.g. Document Management System, Quality Management System)
• Must demonstrate the following behaviors consistently: Innovative, proactive, and resourceful; committed to quality and continuous improvement.
• Able to prioritize, manage time well, multi-task, and troubleshoot effectively.
• Possess project management skills.
• Experience interacting with FDA or other regulatory agencies strongly preferred.
• Strong knowledge of cGMPs and domestic regulatory requirements.
• Knowledge of manufacturing quality (manufacturing, packaging, facilities, critical systems, validation, etc.).
• Must complete tasks independently, notify manager of decisions outside of established processes and the ability to build an internal network.
  
  Vinay Bhatiya
  Associate- Recruitment
  
  PAY RANGE AND BENEFITS:
  Pay Range*: $28.00 - $32.00 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:
  • 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: 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 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.
  
  Thanks,

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