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Quality Assurance Specialist I
Work within a reputable Pharma company in Quality Assurance - Hiring Entry Level
Description:
Performs a wide variety of activities to ensure compliance with applicable regulatory requirements.
Perform administrative duties as such as monitoring quality records and following up with record owners to drive timely closure
Identifies variance from accepted practice through daily triage process
Perform material assessments due to clinical on-site temperature excursions
Perform minor and major investigations related to GxP operations.
Apply Root Cause Analysis tools to identify root causes and propose effective corrective and preventive actions.
Supports management review process through development and generation of quality system metrics and trending, and escalate issues as required.
Support in developing solutions to more complex problems and evaluate impact as necessary.
Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (cGMPs).
May assist with compliance audits as required.
Facilitate cross-functional meetings with internal and external parties as required.
Supports the maintenance and improvement to quality systems processes, as needed
Participate in the development of training programs regarding all aspects of producing quality products, as required.
May be involved in writing and/or implementing changes to controlled documents (e.g., SOPs, Standards, Policies, etc.) as needed.
Skills:
communication and writing skills, gmp environment, gmp, quality assurance
Additional Skills & Qualifications:
• Soft skills -clear communication verbal and email
• Technical skills- pharma experience is not required but always a nice to have, college grads are okay as long as their backgrounds match the skills that are in the JD.
• 0-3 years of experience
About Actalent:
Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.