Quality Assurance Senior Specialist from Innova
West Greenwich, RI
About the Job
Innova Solutions has a client that is immediately hiring for Quality Assurance Senior Specialist
Position type: Fulltime – Contract
Duration: 12 Months
Location: West Greenwich, RI
As Quality Assurance Senior Specialist, you will:
Job Description:
**This is a Hybrid position in clients West Greenwich, RI location** Local candidates only.
**EW will report onsite at least 1-2 days a week and 3 days can be remote.
Hiring Manager Intake Notes:
· What location will this role be tied to? West Greenwich, RI
· Will there be any opportunity for remote work? Yes, EW will need to be onsite at least 1-2 days a week and can work remotely the rest of the week.
· What are the exact shift hours/schedule the contractor will be working/reporting? 8-4 PM
· What is the working environment for this role? Office based
· What type of qualities/characteristics are you looking for in candidates to work best with your team? Experienced QA- self driven
· When reviewing resumes, what stands out to you when looking for the right applicants? Someone who has worked in biotech for years in QA- on the floor experience would be great
· What is your minimum education and years of work experience you think it most suitable for this role? Bachelor's Degree and at least 3 years of experience in QA
Responsibilities: Initiate and coordinate product complaints. Interface with call centers, various clients' sites and business partners to ensure call intake process compliance. Complete and approve product complaints requiring no further investigation. Reconcile reported product complaints to ensure entry in CMIS. Perform return sample coordination and visual assessment. Archive documents related to product complaints. Requirements: Bachelor's Degree in Life Sciences or related field or the equivalent combination of education and/or experience. Typically 2 plus years of related quality assurance or manufacturing experience in a GMP pharmaceutical or medical device industry. Evaluate documentation and operation and documentation according to company guidelines. Be self motivated, attentive to details and able to prioritize and meet deadlines. Basic statistical mathematical skills including the ability to trend data. Basic project management skills. Independently understand, follow and implement instructions. Strong word processing, database and spreadsheet application skills. Strong organizational skills with the ability to manage multiple projects or assignments.
Basic Qualifications
Doctorate degree and 2 years of experience or Master degree and 6 years of experience or Bachelor degree and 8 years of experience or Associate degree and 10 years of experience or high school diploma / GED and 12 years of experience
Top 3 Must Have Skill Sets:
• Demonstrated abilities in problem solving, and experience managing deviation/change control/ CAPA
• Experience in Qualification/Validation including process, equipment and computer validation
• Proven ability to make informed risk-based decisions to drive continuous improvement and maintain quality and compliance.
Day to Day Responsibilities:
• Provide quality advice and oversight to ensure products are manufactured, tested, stored, and distributed according to current good manufacturing procedures.
• Develop and maintain a working understanding of applicable requirements and best practices.
• Leverage knowledge and experience to provide risk-based Quality advice on strategies for successful investigation of deviations; as well as implementation of corrective actions, and change control
• Perform review and approval of GMP processes, procedures, documents, and records, including deviations, corrective actions, change controls, effectiveness verifications, standard operating procedures, batch records, and protocols.
• Review/approve validation documentation, protocols, reports supporting the following qualification/validation disciplines: Equipment, Computer, Process
• Review/approve equipment and computerized systems periodic review reports, as well as environmental qualification protocol reports
• Manage the change control process, ensuring changes are thoroughly evaluated for impact to quality, and strategies for implementation follow clients processes and procedures.
• Collaborate with project teams to integrate quality considerations and controls into project planning and execution.
• Independently assess and prioritize quality risks across various functions and processes.
• Implement proactive measures to prevent potential issues and ensure a state of inspection readiness
• Drive continuous improvement initiatives at the site and network level to create value for the business.
Thank you!
Harish Yadav
Phone: 213-797-4030
harish.yadav@innovasolutions.com
PAY RANGE AND BENEFITS:
Pay Range*: $34.00-$38.00 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:
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.
Position type: Fulltime – Contract
Duration: 12 Months
Location: West Greenwich, RI
As Quality Assurance Senior Specialist, you will:
Job Description:
**This is a Hybrid position in clients West Greenwich, RI location** Local candidates only.
**EW will report onsite at least 1-2 days a week and 3 days can be remote.
Hiring Manager Intake Notes:
· What location will this role be tied to? West Greenwich, RI
· Will there be any opportunity for remote work? Yes, EW will need to be onsite at least 1-2 days a week and can work remotely the rest of the week.
· What are the exact shift hours/schedule the contractor will be working/reporting? 8-4 PM
· What is the working environment for this role? Office based
· What type of qualities/characteristics are you looking for in candidates to work best with your team? Experienced QA- self driven
· When reviewing resumes, what stands out to you when looking for the right applicants? Someone who has worked in biotech for years in QA- on the floor experience would be great
· What is your minimum education and years of work experience you think it most suitable for this role? Bachelor's Degree and at least 3 years of experience in QA
Responsibilities: Initiate and coordinate product complaints. Interface with call centers, various clients' sites and business partners to ensure call intake process compliance. Complete and approve product complaints requiring no further investigation. Reconcile reported product complaints to ensure entry in CMIS. Perform return sample coordination and visual assessment. Archive documents related to product complaints. Requirements: Bachelor's Degree in Life Sciences or related field or the equivalent combination of education and/or experience. Typically 2 plus years of related quality assurance or manufacturing experience in a GMP pharmaceutical or medical device industry. Evaluate documentation and operation and documentation according to company guidelines. Be self motivated, attentive to details and able to prioritize and meet deadlines. Basic statistical mathematical skills including the ability to trend data. Basic project management skills. Independently understand, follow and implement instructions. Strong word processing, database and spreadsheet application skills. Strong organizational skills with the ability to manage multiple projects or assignments.
Basic Qualifications
Doctorate degree and 2 years of experience or Master degree and 6 years of experience or Bachelor degree and 8 years of experience or Associate degree and 10 years of experience or high school diploma / GED and 12 years of experience
Top 3 Must Have Skill Sets:
• Demonstrated abilities in problem solving, and experience managing deviation/change control/ CAPA
• Experience in Qualification/Validation including process, equipment and computer validation
• Proven ability to make informed risk-based decisions to drive continuous improvement and maintain quality and compliance.
Day to Day Responsibilities:
• Provide quality advice and oversight to ensure products are manufactured, tested, stored, and distributed according to current good manufacturing procedures.
• Develop and maintain a working understanding of applicable requirements and best practices.
• Leverage knowledge and experience to provide risk-based Quality advice on strategies for successful investigation of deviations; as well as implementation of corrective actions, and change control
• Perform review and approval of GMP processes, procedures, documents, and records, including deviations, corrective actions, change controls, effectiveness verifications, standard operating procedures, batch records, and protocols.
• Review/approve validation documentation, protocols, reports supporting the following qualification/validation disciplines: Equipment, Computer, Process
• Review/approve equipment and computerized systems periodic review reports, as well as environmental qualification protocol reports
• Manage the change control process, ensuring changes are thoroughly evaluated for impact to quality, and strategies for implementation follow clients processes and procedures.
• Collaborate with project teams to integrate quality considerations and controls into project planning and execution.
• Independently assess and prioritize quality risks across various functions and processes.
• Implement proactive measures to prevent potential issues and ensure a state of inspection readiness
• Drive continuous improvement initiatives at the site and network level to create value for the business.
Thank you!
Harish Yadav
Phone: 213-797-4030
harish.yadav@innovasolutions.com
PAY RANGE AND BENEFITS:
Pay Range*: $34.00-$38.00 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.
Salary
$34 - $38 per hour