Job Title: QA Specialist I (Packaging and Labelling Operations)
We are seeking a highly skilled QA Specialist to join our team on an initial 12-Month contract basis. The successful candidate will be responsible for ensuring the quality of primary and secondary packaging components, as well as reviewing and approving packaging and labelling documents, procedures, and GMP deviations.
Key Responsibilities:
* Perform QA approval and release of primary and secondary packaging components
* Review and approve packaging and labelling documents, procedures, and GMP deviations
* Participate in developing Standard Operating Procedures and controlled documents
* Identify deviations from accepted practices and determine appropriate actions
* Perform QA review and approval of GMP Deviation investigations and CAPAs
* Review and approve Master data and recipes required for operations
* Participate in compliance improvement projects involving cross functional teams
* Maintain programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs)
Requirements:
* Prior experience in pharmaceutical industry is preferred (ideally within a QA role)
* Demonstrates proficiency in Good Manufacturing Practices (GMPs)
* Demonstrates proficiency in application of QA principles, concepts, industry practices and standards
* Demonstrates working knowledge of FDA / EMEA standards and quality systems
* Demonstrates basic knowledge of OPEX Lean tools and root cause analysis tools used for identifying and correcting deviations
* Demonstrates audit and investigation skills, and report writing skills
* Demonstrates good verbal, technical writing and interpersonal skills
* Demonstrates proficiency in Microsoft Office applications
* 3+ years of relevant experience in a GMP environment related field and a BS degree or higher