Quality Assurance Specialist
4 days ago
Almac Group is seeking a highly skilled Quality Assurance Analyst to join our team in Lansdale, PA. As a Quality Assurance Analyst, you will play a critical role in ensuring the quality and compliance of our corporate products and client systems.
Responsibilities:- Certification and Approval: Certify and approve project go-live to production, ensuring compliance with established software development life cycle (SDLC) methodologies and Almac clinical technologies (act) processes and procedures.
- Quality Gate Reviews: Conduct Quality Gate reviews of SDLC deliverables, including IVRS, internal systems, and create initial system Validation Plans and populate Quality Gate Deliverables.
- Project Status and Requirements Meetings: Participate in project status and requirements meetings, when required, and assist in issue resolution and meeting Quality Gate and system certification timelines.
- Live System Maintenance Build Reviews: Conduct live system maintenance build reviews, including completing Sub-build Quality Gates (priority is critical - top 5 clients and studies for upcoming audits) and identifying and reporting trends to Group Leader.
- Live System Periodic Reviews: Conduct live system periodic reviews, including completing periodic review within assigned timeframe, identifying and reporting trends to Group Leader, and performing other work-related responsibilities as assigned by management.
- Resource Management: Manage and prioritize workload, escalate conflicting schedules to management, facilitate the timely delivery of all client (internal and external) deliverables, and perform other work-related responsibilities as assigned by management.
- Other Responsibilities: Assist management in reviewing and approving ACT Standard Operation Procedures (SOPs) and Working Instructions (WIs), perform staff training on Quality-related topics, and provide GCP, FDA, ICH, general regulatory, and internal procedure guidance to the organization.
- Required Experience/Education: A Bachelor's degree in Science or related field OR Associates degree at least two years previous experience within a Pharmaceutical environment and/or Quality Role.
- Preferred Experience/Education: IVRS systems, Software development principles, concepts, and methods (e.g., Computer System Validation (CSV), Agile, WaterFall), 21 CFR Part 11 (EU Annex 11), HIPAA, Safe Harbor, General Principles of Software Validation, and other FDA/EU regulatory requirements and guidance documents, experience working in a related Quality role: auditing or CAPA management, understanding of basic quality principles, familiarity with the clinical trial process and related industries, knowledge of IRT development and support tools (proprietary or public domain), and ASQ Certification.
- Medical, Vision & Dental Benefits: Full medical, vision, and dental benefits the 1st of the month after start date.
- PTO and Holidays: 20 days of PTO to start plus 12 holidays per year.
- Disability and Life Insurance: Company-paid long and short-term disability along with life insurance.
- 401k: Company match.
- Professional Development: Professional development programs/continuous learning opportunities.
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