Description : Note :
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.
3 roles. One position will be a 6-month contract, and the other two will be 12-month contracts
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 activitiesReview 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 programAble to act as SME for multiple Quality processes (e.g. Deviations, CAPA)Review and Approve SOPs and associated documentsReview / Approve Periodic Reviews for GxP SystemsMay perform software Supplier Evaluations as neededSupport project initiatives, process improvements and or projectsMay be required to present on topics or issues to managementMay support audit & Inspections requests as neededMay support other duties as requiredSkills & 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 neededCollaborate 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 managementAbility to lead and influence staff outside QA organizationAble to manage performance issues and conflictAbility 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 problem-solving abilities and strong risk assessment capabilitiesBasic Qualifications
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 experienceWill consider those that have significant years of direct experience in lieu of education requirementsOrg Unit : GxP Computer Systems Quality Assurance 13228Top 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 guidelinesAbility to interpret and apply GMP, GLP, GCP, GPvP regulationsPay Rate between $54 - $61 / Hr on W2 based on experience.
This posting is for Contingent Worker, not an FTE"
Salary : $54 - $61
