Performs Quality Assurance tasks that supports GMP-compliant operations in an API manufacturing facility.
Drafts technical documents, such as specifications and operating instructions, based upon information provided by other departments, standard procedures, and quality requirements.
Performs detailed reviews of documentation related to GMP activities.
Routes, tracks and completes documents in the electronic document systems and ensures that entries are accurate and current.
Updates and maintains various databases as needed. Assists with the issuance and maintenance of controlled documents.
Types, scans/copies, distributes/retrieves, and files controlled documents and records as required.
Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs).
Participates in continuous improvement initiatives based on international regulations and industry best practices.
Prioritizing tasks to ensure the critical tasks are completed on time and meet requirements.
Participates in site inspection readiness and the site internal audit program, including site walkthroughs.
Qualifications
A BS or BA degree in a scientific area or a high school diploma and minimum 3 years of relevant experience.
Must be able to think critically and creatively, be able to work independently, determine appropriate resources for resolution of problems, and have strong organizational and planning skills.
Demonstrates excellent communication (verbal and technical writing) skills and strong interpersonal skills.