A client of Innova Solutions is immediately hiring for the Quality Assurance Manager.
Position type : Full-time– Contract
Duration : 4 Months
Location : REMOTE
As Quality Assurance Manager, you will :
Job Description :
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.
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
Skills & Behaviors :
Validation and Change Control experience (Highly preferred : Risk Based Validation experience and or strong Computer System Assurance (CSA) knowledge)Ability to lead and influence staff outside QA organizationAbility to evaluate documentation / operations according to company and regulatory guidelinesAbility to interpret and apply GMP, GLP, GCP, GPvP regulationsPreferred 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 principlesDemonstrated strong risk assessment capabilitiesEducation :
Master’s degree in technical or related subject and 3 years with directly experienceBachelor’s degree in technical or related subject and 5 years with directly experienceThank you!
Lailun Sheikh
Phone :
PAY RANGE AND BENEFITS :
Pay Range
: $55.00-$60.00 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).