Essential Duties and Job Functions:
·Participates within inter-departmental and cross-functional teams
·Performs a variety of activities to ensure compliance with applicable cGxP regulatory requirements
1. Reviews routine release documentation for Packaging Components & Starting Materials
2. Reviews Supplier investigations, Temptales and disposal of expired items
3. Assists in approval of aspects of new Material introduction
4. Assists with investigations and corrective and preventive action (CAPA) relating to materials/components/batches.
·May assist with QA support for Quality Control, Warehouse and Materials Management areas when required
5. Participates in authoring, reviewing and approving Standard Operating Procedures (SOPs)/other types of controlled documents
6. Performs internal audits and walkthroughs on behalf of the QA department to ensure site compliance to GMP
·Works on assignments that are routine in nature, where ability to recognize deviation from accepted practice is required.
·Exercises judgment within defined procedures and practices to determine appropriate action
·Normally receives very little instruction on routine work, general instructions on new assignments
Knowledge, Experience and Skills:
·Prior experience in pharmaceutical industry is preferred (ideally within a QA role, with also QC experience)
7. Working knowledge of current Good Manufacturing Practices (cGMPs) (FDA / EMEA standards and quality systems)
8. Demonstrates working knowledge of quality assurance systems, methods and procedures.
9. Basic knowledge of OPEX Lean tools, and root cause analysis tools used for identifying and correcting deviations.
10. Demonstrates audit and investigation skills, and report writing skills.
11. Good verbal, written, and interpersonal communication skills.
12. Proficiency in Microsoft Office applications.
Typical Education & Experience:
13. 4+ years of relevant experience in a GMP environment related field and a BS.