Quality Assurance Manager

Innova Solutions has a client that is immediately hiring a Quality Assurance Manager.

Position type: Full-time - Contract
Duration: 6 Months
Location: Remote

As a Quality Assurance Manager, you will:

Description

Part Time - 20 Hours/Week

Ideal candidate:
Computer Systems Validation experience is mandatory. Ability to interpret and apply GMP, GLP, and GCP regulations. Validation and change control experience is required. Strong documentation, operational, and guideline compliance experience. No specific degree requirement candidates with extensive Computer Systems Validation experience are acceptable regardless of their degree field. Strong communication skills (written and verbal). A team player who can collaborate effectively. Ability to handle escalations professionally and de-escalate conflicts. Must be proactive and engaged, rather than just following procedures passively.

Nice-to-Have:
Experience working with Veeva or Safety Systems is a plus but not required.
Knowledge of industry-wide regulatory systems

Duties:

• Act as Quality Assurance (QA) contact for Change Control(s) for Computerized System activities
• Review and Approve validation deliverables (e.g. Validation Plan, Requirement Assessment, support Testing Protocols, Summary Reports, etc.)
• Change Agent and advocate for the Risk Based Validation program
• Able to act as SME for multiple Quality processes (e.g. Deviations, CAPA)
• Review and Approve SOPs and associated documents
• Review/Approve Periodic Reviews for GxP Systems
• May perform software Supplier Evaluations as needed
• Support project initiatives, process improvements and or projects
• May be required to present on topics or issues to management
• May support audit & Inspections requests as needed
• May support other duties as required

Skills & Behaviours:

• Validation and Change Control experience (Highly preferred: Risk Based Validation experience and or strong Computer System Assurance (CSA) knowledge)
• Initiate and lead cross functional teams as needed
• Collaborate and communicate with higher level outside resources.
• Strong skill in working independently and to effectively interact with various levels of management
• Ability to lead and influence staff outside QA organization
• Able to manage performance issues and conflict
• Ability to evaluate documentation/ operations according to company and regulatory guidelines
• Ability to interpret and apply GMP, GLP, GCP, GPvP regulations

Preferred Qualification

• 5+ years' experience in a regulated industries in a similar role (e.g. Biotechnology, Medical Device, Aerospace)
• Demonstrated strong Knowledge of industry and business principles

Education:

• Master's degree in technical or related subject and 3 years with directly experience
• Bachelor's degree in technical or related subject and 5 years with directly experience
• Will consider those that have significant years of direct experience in lieu of education requirements

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.
Pradip Joshi
Email -

Phone:


PAY RANGE AND BENEFITS:

Pay Range : $55- $60/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, )
• One of the Largest IT Staffing Firms in the US Ranked by Staffing Industry Analysts (SIA, 2024)
• One of the Largest Staffing Firms in the US Ranked 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

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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.

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

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 call
. 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.
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