Sr. QAV Specialist

Innova Solutions Inc; Bedford (MA); On-site; USD 96,000 - 110,000; Full time

Benefits offered by this job

Medical & pharmacy coverage

Dental/vision insurance

401(k)

Job summary

Innova Solutions is seeking a Sr. QAV Specialist for a 12-month on-site contract in Bedford, MA. The role focuses on QA validation activities, approvals, and lifecycle documentation within a GMP biopharma setting.

Responsibilities include review/approval of AIQ, data integrity, BMRAM, and regulatory documentation, with an emphasis on compliance with FDA/EMA standards.

Qualifications

• Must have experience in biopharmaceutical or biotechnology GMP operations with Quality/Validation roles.
• Direct experience with analytical instrument qualifications, computer system validation and data integrity programs.
• Knowledge of FDA and EMA regulations.
• Direct experience reviewing and/or authoring CMC sections of regulatory filings.

Responsibilities

• Review and approval of AIQ protocols, reports, validation issues, specifications and assessments.
• Review and approval of periodic reviews for manufacturing.
• Review and approval of data integrity assessments and audit trail reviews for manufacturing.
• Review and approval of BMRAM work orders for manufacturing.
• Review and approval of equipment, facility and utility system validation lifecycle documents.

Skills

Biopharmaceutical GMP experience

Quality/Validation roles

Analytical instrument qualifications

Computer system validation

Data integrity programs

Education

Bachelor of Science in Engineering or related Sciences

Tools

Analytical instrument qualifications

Computer system validation

Data integrity programs

Job description

A client of Innova Solutions is immediately hiring for the Sr. QAV Specialist.

Position type: Full-time- Contract Duration: 12 Months Location: Bedford, MA 01730 (ONSITE)

Provide onsite QAV support following QAV activities:

Responsibilities

• Review and approval of analytical instrument qualification (AIQ) protocols, reports, validation issues, specifications, and assessments.
• Review and approval of periodic reviews for manufacturing.
• Review and approval of data integrity assessments and audit trail reviews for manufacturing.
• Review and approval of BMRAM work orders for manufacturing.
• Review and approval of equipment, facility, and utility system validation lifecycle documents (e.g., SLRA (System Level Risk Assessments), DI (Data Integrity) Assessments, DR/DQ, Specifications, IQ/OQ/PQ Qualification Protocols/Issues/Reports, Risk assessments (potential to facilitate risk assessments)).

Qualifications

• Minimum B.S. degree in Engineering or other Science field such as microbiology, chemistry or biochemistry.
• Experience in biopharmaceutical or biotechnology based GMP operations with experience in Quality and/or Validation roles.
• Direct experience with analytical instrument qualifications, computer system validation/computer software assurance, and data integrity programs.
• Knowledge of relevant FDA and EMA regulations.
• Direct experience reviewing and/or authoring CMC sections of regulatory filings.

Pay Range and Benefits

Pay Range: $70.00-$80.00 per hour.

Benefits

• 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 offers referral bonus for qualified Ambassadors who refer eligible referrals. Submit referrals at https://innovasolutions.workllama.com/atsuser/anonreferafriend and earn $250-$1,000 per referral.

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 your job search or application for employment, please contact us at [email] or [phone]. 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.