AstraZeneca Pharmaceuticals LP Quality Assurance Specialist - Global Operations in Coppell, Texas
At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with the upmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people’s exceptional skills with those of people from all over the globe.
The Quality Assurance Specialist provides support in the development and maintenance of the Quality Management System within a facility manufacturing Active Pharmaceutical Ingredients. This hands-on Specialist role is focused on supporting Operations personnel in the manufacturing facility and facilitating compliance with site Standard operating procedures, work instructions, development studies, ensuring adherence to applicable GMP regulations. The incumbent will act as the quality Business Process Owner for quality systems/process (for example - document management, deviation and CAPA, Complaints, Change Control, External Audit process). The role will also be involved in writing Standard Operating Procedures, conducting and documenting investigations, auditing manufacturing and quality processes, batch record issuance, and other quality systems activities as assigned.
Develop, implement and maintain Quality Assurance processes and systems.
Business Process Owner for External Audit process
BPO for complaint process (PQCs, direct material suppliers), including Super User role for GCM.
Lead / participate in internal Quality System / cGMP audits.
Escalates to QA Line Manager potential issues of non-compliance.
Write, edit, and review Standard Operating Procedures and various Quality related technical documents (protocols, specification, work instructions, batch records, etc.) in a highly collaborative environment.
Coordinate collection of information / data for and generation of PQR.
Assist with driving completion of AZ integration activities
Assist with site activities related to support of regulatory submissions
Provide Process/Quality Engineering support to manufacturing operations, helping to ensure delivery of highest quality product to the customer, as needed.
Conduct Quality Event investigations (Nonconformance / failure, deviation, CAPA, etc.) and document in appropriate reporting methods and systems, as needed.
Participate/lead inspections conducted by regulatory organizations.
Bachelors degree in a science or engineering curriculum
A minimum of three to five years of experience as a Quality Assurance professional in the pharmaceutical manufacturing industry (finished drug product or Active Pharmaceutical Ingredients / complex chemical processing of excipients).
Must be able to demonstrate proficiency in verbal and written communication in English.
Must be familiar with and competent in the use of Microsoft Word, Excel, and PowerPoint.
Must be willing to address emergent factory quality and compliance issues by being available via telephone during off hours.
Knowledge of cGMP requirements, quality systems, and pharmaceutical manufacturing/packaging technologies; experience in regulated environments.
Next Steps – Apply today!
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AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.