Job Description
Description: REMOTE: PST hours preferred (EST hours okay) - STANDARD 8-5
Candidates may need to work outside normal business hours on occasion, particularly once per quarter for system releases.
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
- Org Unit: GxP Computer Systems Quality Assurance 13228
Top 3 Must Have Skill Sets: - Validation and Change Control experience (Highly preferred: Risk Based Validation experience and or strong Computer System Assurance (CSA) knowledge)
- Ability to evaluate documentation/ operations according to company and regulatory guidelines
- Ability to interpret and apply GMP, GLP, GCP, GPvP regulations
Pay Rate $54 - $61 on W2 based on experience. "This posting is for Contingent Worker, not an FTE"
Job Tags