QA Specialist I

• Performs a wide variety of activities to ensure compliance with applicable cGxP regulatory requirements.
• Participates in developing Standard Operating Procedures and writes and/or implements changes to controlled documents to ensure quality objectives are met.
• Participates in reviewing and approving Standard Operating Procedures (SOPs)/other types of controlled documents.
• Performs QA review and release of primary and secondary packaging components.
• May participate in QA review and approval of artwork.
• Identifies deviations from accepted practices, exercises judgement to evaluate impact and determines appropriate actions
• QA Review and approval of GMP Deviation investigations and CAPAs
• QA Review and approval of Master data and recipes required for operations
• May participate in data gathering exercises, to develop and maintain QA metrics.
• Participate in compliance improvement projects involving cross functional teams.
• May assist with compliance audits and walkthroughs as required on behalf of the QA department to ensure site compliance to GMP.
• Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs).
• Normally receives very little instruction on routine work, general instructions on new assignments.

• 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 Prior experience in pharmaceutical industry is preferred.
• 4+ years of relevant experience in a GMP environment related field and a BS.
• 3 + years of relevant experience and a MS.

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