Clarity Pharmaceuticals · 22 hours ago
Quality Associate
United States
Full-time
Remote
Mid, Senior Level
5+ years exp
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Responsibilities
Prepare, review / approve and maintain essential documents within Quality Management System (QMS), including but limited to quality system registers and training on QMS
Participate in writing and implementing Deviations, Investigations, CAPA and Change Control reports
Participate in the preparation of the manufacturing and quality sections for regulatory submissions
Participate in the management of internal quality audits on all systems within the QMS, prepare reports and recommend solutions and close out activities under the guidance of AD Quality
Participate in the management of supplier quality audits and agreements
Engage and effectively manage CMOs (vendors involved in manufacture, analysis and release of drug) and other external suppliers to ensure delivery on time and complies with GMP/GLP requirements as directed
Collaborate with production / manufacturing teams to monitor all work according to requirements under quality system
Review and evaluate all standard operating procedures, batch records and quality control results to ensure compliance with quality and regulatory requirements
Release the clinical trial products as needed
Provide support to cross-functional teams
Build a positive culture within the Regulatory and Quality teams as well as cross-functionally
Qualification
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Required
Degree qualified preferably in Pharmacy, Health and/or a related discipline
Ideally 5+ years Quality experience within a pharmaceutical/biotech
A good understanding of the pharmaceutical and clinical drug development process
Excellent oral and written communication, organizational, and problem-solving skills while working under strict timelines
Ability to convey complex ideas in a simple manner to management and stakeholders
Experience in working within matrix teams
Demonstrated ability to work independently
Team oriented mindset and demonstrates ability to work with cross functional teams
Fluent in Microsoft Office suite (Word, Excel, SharePoint, Teams, etc.) and experienced in working in mainly electronic record-keeping environment
The ability to work out of normal business may be required on occasion, this is to support the needs of a global business
Efficient time management skills to complete work within required timeframes and excellent attention to detail
Company
Clarity Pharmaceuticals
Clarity Pharmaceuticals is a personalized medicine company focused on the treatment of serious disease.
11-50 employees
Funding
Current Stage
Public CompanyTotal Funding
$9.67MKey Investors
Australian Nuclear Science and Technology OrganizationSydney Angels
2021-08-25IPO· undefined
2017-06-29Series Unknown· $3.07M
2016-07-18Grant· $2.5M
Leadership Team
Colin Biggin
CEO and Managing Director
Matt Harris
Co-Founder and Chief Scientific Officer
Company data provided by crunchbase
