United States onlyAbout Us:
Endpoint is an interactive response technology (IRT®) systems and solutions provider that supports the life sciences industry. Since 2009, we have been working with a single vision in mind, to help sponsors and pharmaceutical companies achieve clinical trial success. Our solutions, realized through the proprietary PULSE® platform, have proven to maximize the supply chain, minimize operational costs, and ensure timely and accurate patient dosing. Endpoint is headquartered in Raleigh-Durham, North Carolina with offices across the United States, Europe, and Asia.
Position Overview:
The role of Quality & Compliance Analyst, Senior is primarily responsible for direct action and oversight of the day-to-day operations of ensuring compliance for product release launch activities and post-launch compliance and ensuring compliance as set forth by regulatory agencies and endpoint Quality Management System (QMS) as well as participate and lead continued growth/improvement projects.
Responsibilities:
- Serve as the primary point of contact for resourcing and guidance of the Product Release team.
- Review and approve in-process tasks related to product and/or service provision.
- Develop and oversee onboarding and training programs for Analysts within the Product Release team.
- Act as the subject matter expert and point of contact for the Software Development Life Cycle (SDLC) process.
- Develop, draft, and revise controlled Validation Deliverables, while driving continuous improvement of product release procedures and practices.
- Provide ad hoc training to Operations staff on compliance procedures associated with product release activities.
- Product Release Responsibilities:
- Review and approve in-process tasks related to product and/or service provision.
- Generate, review, and maintain Validation Deliverables documentation, ensuring compliance with established procedures and processes.
- Maintain validation documentation within the Quality Management System (QMS) in accordance with company procedures.
- Support Operations staff in the development, drafting, and revision of controlled Validation Deliverables.
- Act as the primary representative and resource to Operations staff regarding product release matters.
- Assist in the preparation, review, and maintenance of reports related to identified product events.
- Participate in Root Cause Analysis (RCA) meetings with Operations and provide input on the identification and documentation of Corrective and Preventive Actions (CAPA) for discrepancies or product failures.
- Support completion of outstanding CAPA items in collaboration with appropriate stakeholders, as they relate to product release.
- Assist the Governance unit in preparing for external audits related to product release activities.
- Perform Quality Control (QC) reviews of controlled Quality Management System (QMS) documents, including SOPs, Work Instructions, and Policies, and provide feedback to relevant stakeholders as needed.
Education:
- M.S. degree and minimum 2 years of related experience OR BS/BA degree and minimum 4 years of related experience
- Certification in Quality Assurance or Regulatory Affairs preferred
Experience:
- Minimum 2-4 years of relevant working experience within a regulated environment
- Substantial working knowledge of FDA regulations (21 CFR Part 11, EU Annex 11) regulations and current industry best practices
- Knowledge of U.S. and international regulatory standards and guidelines
- Relevant experience preferably in the clinical trial industry, IRT, or CRO experience is highly desired.
- Experience with a QMS and LMS preferred
Skills:
- Strong communication (written and verbal), organizational, and interpersonal skills.
- Strong decision-making skills
- Project management skills and high level of attention to detail.
- Demonstrated ability to work in a fast-paced, cross-functional team environment.
- Position requires a highly diplomatic and tactful individual with exceptional critical reasoning skills
- Experience in developing SOPs in for quality assurance and compliance.
- Strong collaboration and development skills.
- Proactive team player enthusiastic with high work ethics
- Proficient in Microsoft Office applications (Outlook, Word, Excel, Visio, Microsoft Project, Power Point) and Adobe Acrobat Professional.
Endpoint Clinical does not accept unsolicited resumes from search firms or any other third parties. Any unsolicited resume sent to Endpoint Clinical will be considered Endpoint Clinical property, and Endpoint Clinical will not pay a fee should it hire the subject of any unsolicited resume.
Endpoint Clinical is an equal opportunities employer AA/M/F/Veteran/Disability.
Pursuant to the San Francisco Fair Chance Ordinance, we will consider for employment, qualified applicants with arrest and conviction records.
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