Job Description:

Innova Solutions has a client that is immediately hiring for Quality Assurance Senior Specialist.


Position type: Fulltime - Contract

Duration: 12 Months

Location: 100% REMOTE


As Quality Assurance Senior Specialist, you will:


Job Description: Primary focus is the support and oversight of Client's Quality Management Systems ensuring key requirements and initiatives are implemented, maintained and reviewed in accordance with cGMP regulations. Additional detail responsibilities, accountabilities or decision authorities are defined in procedures to execute assigned task for the role and deployed through assignment of procedure training in the Learning Management System. Responsibilities could include:

• May be responsible for leading and directing the Quality functions for assigned plant(s) or functional area(s)

• Responsible for providing Quality oversight to ensure that Cleint's systems are executed, according to current Good Manufacturing Practices (cGMP) and other applicable regulations

• Ensures that Quality Management Systems comply with cGMP practices and other applicable regulations

• Provide support for Global Process Owners executing key quality systems processes

• Ensures the Quality unit provides review, approval and tracking of cGMP processes, procedures, assays, documents and records, including nonconformances, CAPAs, change control records and validations. May execute these tasks

• Supports Continual Improvement initiatives, programs and projects

• Ensures that changes that could potentially impact product quality are assessed according to procedures

• Ensures that deviations from established procedures are investigated and documented per procedures

• Collect and analyze Key Process Indicator (KPI) data to assessing process performance and areas of improvement

• Alerts senior management of significant quality, compliance, supply and safety risks


Must Have Skill Sets:

Primary:

1- Quality Management Systems experience (up to and including ownership of a quality system element, implementation of a quality system element)

2- Regulatory Compliance experience (up to and including experience presenting to a regulatory authority, ensuring GMP processes are aligned to regulations)

3- Ability to coordinate with cross functional teams and management chain


Nice to haves:

1- KPI data collection and analysis with presentation to leadership at management reviews

2- Strong systems understanding (Microsoft suite, Veeva platform, Trackwise, etc.)

3- History of general GMP execution (Deviations, Change Controls, CAPA, Disposition of Product, Regulatory Deviation Reporting, Recalls)


Day to Day Responsibilities:

This role will be supporting the Corporate Quality Management Systems team, this person will have exposure to Recall, Regulatory Reporting of Deviations, Disposition, Deviation/CAPA processes and supporting of the GPO of those processes. Additionally, these individuals could be asked to support initiatives of the Quality Systems Director.


These individuals will be expected to execute tasks with minimal oversight to ensure processes are meeting requirements and requests of our customers. These tasks could be to lead focused initiatives to support site requests and needs, manage tactical execution of GPO responsibilities including report generation, meeting facilitation, problem resolution and issue escalation.


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.


Thank you!

Lailun Sheikh

Phone: 412-763-1477

Lailun.Sheikh@innovasolutions.com


PAY RANGE AND BENEFITS:

Pay Range*:$32.00-$37.00 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 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. Apply Now