Sr. QAV Specialist
Job Location:
Bedford, NH - USA
Hourly Salary:
Posted:
Application Deadline:
Vacancies:
Job Summary
Position type:Full-time Contract
Duration:12Months
Location:Bedford MA01730(ONSITE)
AsSr. QAV Specialistyou will:
Job Description:This contract position is for a lead QA Validation contract role supporting the Clients Site.
Responsibilities
Provide onsite QAV support following QAV activities:
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 tofacilitaterisk assessments)).
Qualifications
Minimum B.S. degree in Engineering or other Science field such as microbiologychemistryor 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.
Qualified candidates shouldAPPLY NOWforimmediateconsideration!Pleasehit 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!
Lailun Sheikh
Phone:
PAY RANGE AND BENEFITS:
Pay Range*:$70.00-$80.00per hour.
*Pay range offered to a successful candidate will be based on several factors including the candidates 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 50000 professionals worldwide and reports an annual revenue approaching $3 Billion. Through our global deliverycentersacross North America Asia and Europe we deliver strategic technology and business transformation solutions to our clients enabling them tooperateas leaders within their fields.
Recent Recognitions:
- NamedOne of Americas Best Employers for New Grads by Forbes (2024
- Named One of the Best Companies to WorkForby 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: Solutions offers a referral bonus for qualified Ambassadors who refer eligible referrals. Submit referrals at earn$250-$1000 per referral.
Innova Solutionsis 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 racecolor 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 toassistwith your job search or application for employment please contact us . Pleaseindicatethe specifics of Solutions encourages all interested and qualified candidates to apply for employment Solutions (HireGenics/Volt) does not discriminate against applicants based on citizenship status immigration status or national originin accordance with8 U.S.C. 1324b.
The company will consider for employment qualified applicants with arrest and conviction records in a manner thatcomplies withthe San Francisco Fair Chance Ordinance the Los Angeles Fair Chance Initiative for Hiring Ordinance and other applicable laws.
Required Experience:
Senior IC
