What are the responsibilities and job description for the Quality Assurance Manager position at Aequor Technologies LLC?
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 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
