QA Analyst working on testing strategy for internal applications at Focus Group. Collaborating closely with development team to ensure product quality and stability.
About the role
- Quality Assurance Specialist ensuring compliance with regulations and quality in clinical supply chain for pharmaceutical company. Responsible for oversight of clinical supply materials and processes.
Responsibilities
- safeguard the rights and well-being of patients; the welfare of animals; comply with applicable global regulatory requirements through sound processes and procedures
- provide independent assurance that delivers high quality data and clinical supplies
- Evaluation and disposition of clinical supply materials with the assurance that the materials were produced in conformance to all applicable policies/procedures of our Company and compliance with all governing regulations
- Coordinate and/or support the preparation of procedures, processes and quality improvements
- Assists in the coordination of significant quality events including fact finding, investigation, coordination of clinical quarantine and recovery actions
- Collaboration across cross-functional and business areas to ensure robust processing, continuous improvement and cross-functional team building
- Providing on-the-floor coaching/guidance of operational and technical issues; providing immediate resolution on the shop floor to deviations and potential deviations
- Completing projects to improve the performance of our processes, including continuous process improvements, investigation Corrective/Preventative Actions (CAPAs), and value capture projects that seek to improve outcomes, reduce cost, or lower our processing cycle times
- Managing investigation, change request and project timelines to ensure key compliance and customer due dates are met; escalating any potential misses and develop remediation plans when possible
- Actively using and championing the use of Lean Six Sigma (LSS) and our Company's Production System (PS) tools, both in problem-solving and day-to-day operational activities
Requirements
- Bachelor's degree with a concentration in a scientific-related discipline
- Minimum of 5 year's experience in the pharmaceutical or equivalent industry Good Manufacturing Practice (GMP) related field
- Familiarity with batch disposition (release) activities
- Prior experience reviewing and approving investigations, deviation management support, and Corrective/Preventative Actions (CAPAs)
- Background in quality control, quality assurance, auditing or regulatory affairs
- In-depth working knowledge of cGMPs and of regulatory requirements as they apply to the pharmaceutical field or a related area
- Basic understanding of the use and maintenance for Microsoft applications (such as Excel, Outlook, Access)
Benefits
- medical
- dental
- vision healthcare and other insurance benefits (for employee and family)
- retirement benefits, including 401(k)
- paid holidays
- vacation
- compassionate and sick days
Job title
Job type
Experience level
Salary
Degree requirement
Location requirements
Quality Engineer ensuring product quality and supporting manufacturing processes in Oulu, Finland. Collaborating with global teams and suppliers to maintain high quality standards.
QA Engineer testing AI agents for a European AI scale - up. Responsible for ensuring compliance and preventing platform risks.
SDET ensuring quality for Hybrid Cloud tooling enabling SaaS provisioned Epicor Applications on customer managed infrastructure. Collaborating with teams to deliver high - quality software and mentoring junior engineers.
Senior Automation QA Engineer testing backend applications for EveryMatrix, with responsibilities including framework building and executing test scripts.
Senior Quality Engineer ensuring high - quality gaming and wagering products. Driving test strategies and automation improvements in a hybrid work environment.
QA Specialist responsible for managing quality assurance systems at Cook Medical Korea. Implementing quality improvement initiatives and coordinating audits complying with regulations.
Senior QA testing functional scenarios at DOMVS iT. Collaborating closely with Product and Development teams in an agile environment.
QA Product Manager ensuring quality assurance for pharmaceutical products in collaboration with cross - functional teams. Leading third - party manufacturing quality efforts and compliance with regulatory standards.
Quality Assurance Technician performing inspections and testing at Dura - Line. Collaborating with production to uphold safety and quality standards.