Specialist, QA Engineering from Innova
Warren, NJ
About the Job
Innova Solutions has a client that is immediately hiring for a QA Engineering Specialist
Position type: Full-time, Contract
Duration: 08 months
Location: Warren NJ Onsite
As a QA Engineering Specialist, you will:
Responsible for providing quality oversight on technology transfer into and out of the site, process understanding and enhancement, and other site qualification activities in a fast-paced, highly collaborative manufacturing facility. This team supports the Cell Therapy Development early clinical drug product manufacturing facility, which supplies autologous and allogeneic cell therapies for first-in-human and pivotal clinical trials.
Duties/Responsibilities :
QA lead on technology transfer activities (process):
Ensure technology transfers on new product introduction and/or new trials and cohorts are compliant with internal standards and/or regulatory requirements, as applicable.
Maintain knowledge of scientific literature, regulatory guidelines, internal standards/procedures and apply key concepts during project activities/plans.
Interact and coordinate with other QA functional teams to ensure timely completion of QA related activities.
Interact and collaborate with cross-functional teams to achieve common goals
Provide training to QA colleagues on new product manufacturing process, as applicable to ensure clinical production readiness.
Must be knowledgeable on change control process.
Must be knowledgeable on the process and associated methods for the assigned product.
Support Product/Program Lifecycle Management Activities
Support change initiatives and implementation of new technologies, process and method improvements, material changes and ensure compliance with internal standards and regulatory requirements.
Support regulatory filings and amendments, as applicable (i.e. IND, INDa, CTA etc.)
Participate and drive Quality Risk Management (QRM) initiatives at the site to ensure risk areas are identified and risk control measures are implemented.
Review media simulation activities to ensure successful execution and documentation.
Maintain data integrity by ensuring procedures/processes are compliant with internal data integrity standards and procedures.
Work with Engineering/Facilities/Warehouse/Supply Chain/Manufacturing Operations/Quality Control management to ensure functional activities comply with internal standards and regulatory requirements.
EDUCATION AND EXPERIENCE
B.S. degree required.
Minimum of six years of experience in the pharmaceutical or related industry.
Equivalent combination of education and experience acceptable.
REQUIRED COMPETENCIES
Must have strong understanding of global cGMP, quality systems (especially change management), and guidance documents.
Must have knowledge of technology transfer for manufacturing processes.
Must have strong authorship and be able to critically review investigations and reports, interpret results, and generate technical conclusions consistent with quality risk management principles.
Must have strong quality background.
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
Sara.Almas@innovasolutions.com
PAY RANGE AND BENEFITS:
Pay Range*: $60- $64.00 /hr.
*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:
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: Full-time, Contract
Duration: 08 months
Location: Warren NJ Onsite
As a QA Engineering Specialist, you will:
Responsible for providing quality oversight on technology transfer into and out of the site, process understanding and enhancement, and other site qualification activities in a fast-paced, highly collaborative manufacturing facility. This team supports the Cell Therapy Development early clinical drug product manufacturing facility, which supplies autologous and allogeneic cell therapies for first-in-human and pivotal clinical trials.
Duties/Responsibilities :
QA lead on technology transfer activities (process):
Ensure technology transfers on new product introduction and/or new trials and cohorts are compliant with internal standards and/or regulatory requirements, as applicable.
Maintain knowledge of scientific literature, regulatory guidelines, internal standards/procedures and apply key concepts during project activities/plans.
Interact and coordinate with other QA functional teams to ensure timely completion of QA related activities.
Interact and collaborate with cross-functional teams to achieve common goals
Provide training to QA colleagues on new product manufacturing process, as applicable to ensure clinical production readiness.
Must be knowledgeable on change control process.
Must be knowledgeable on the process and associated methods for the assigned product.
Support Product/Program Lifecycle Management Activities
Support change initiatives and implementation of new technologies, process and method improvements, material changes and ensure compliance with internal standards and regulatory requirements.
Support regulatory filings and amendments, as applicable (i.e. IND, INDa, CTA etc.)
Participate and drive Quality Risk Management (QRM) initiatives at the site to ensure risk areas are identified and risk control measures are implemented.
Review media simulation activities to ensure successful execution and documentation.
Maintain data integrity by ensuring procedures/processes are compliant with internal data integrity standards and procedures.
Work with Engineering/Facilities/Warehouse/Supply Chain/Manufacturing Operations/Quality Control management to ensure functional activities comply with internal standards and regulatory requirements.
EDUCATION AND EXPERIENCE
B.S. degree required.
Minimum of six years of experience in the pharmaceutical or related industry.
Equivalent combination of education and experience acceptable.
REQUIRED COMPETENCIES
Must have strong understanding of global cGMP, quality systems (especially change management), and guidance documents.
Must have knowledge of technology transfer for manufacturing processes.
Must have strong authorship and be able to critically review investigations and reports, interpret results, and generate technical conclusions consistent with quality risk management principles.
Must have strong quality background.
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
Sara.Almas@innovasolutions.com
PAY RANGE AND BENEFITS:
Pay Range*: $60- $64.00 /hr.
*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
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
Competitive