Website US Tech Solutions, Inc.
US Tech Solutions, Inc.
Company : US Tech Solutions, Inc.
Job Details:
Duration: 04 months contract
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 & Behaviors:
- Validation and Change Control experience (Highly preferred: Risk Based Validation experience and or strong Computer System Assurance (CSA) knowledge)
- Strong organizational skills, including ability to follow assignments through completion.
- Initiate and lead cross functional teams as needed
- Collaborate and communicate with higher level outside resources.
- Strong communication (both written and oral), facilitation, and presentation skills.
- 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
- Demonstrated strong problem-solving abilities and strong risk assessment capabilities
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
Basic Qualifications:
- Doctorate degree OR Master degree and 3 years of experience OR Bachelor degree and 5 years of experience OR Associate degree and 10 years of experience OR High school diploma / GED and 12 years of experience
Top 3 Must Have Skill Sets
- Prior experience with Computer Systems validation and risk-based decision making
- Project management experience preferred
- Ability to evaluate documentation/operations according to company and regulatory guidelines
Day to Day Responsibilities:
- Review and Approve validation documents (e.g. Validation Plans, Specifications, Design Specifications, User and Functional Requirements, Testing Protocols, Summary Reports, and Requirement Traceability Matrices)
- Review and Approve operational and administrative SOPs
- Review and Approve Change Controls (QA Contact/Owner)
- Apply analytical skills to evaluate and interpret complex situations/problems
- Present/provide Risk-Based Validation training & workshops
- Assist/lead validation strategy and risk-based requirements profiling
- Work independently with little day-to-day supervision
About US Tech Solutions:
US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit (url removed).
US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.