Finishing Shift Lead (2nd shift)

Description

Non-Negotiable Requirements:

• Minimum of 1-year experience as a qualified inspector of parenteral products.
• Experience and expertise of regulated products with a thorough understanding of cGMP, FDA guidelines.

Preferred Requirements:

• Experience in supervision.
• BS or BA in Business/Marketing, Biopharmaceuticals, or other Life Sciences field and/or equivalent experience.

Responsibilities Include (but are not limited to):

• Establish, develop, and maintain procedures and processes for visual inspection of finished product and incoming materials.
• Establish, develop, and maintain visual inspection training process, procedures, records, and qualification of visual inspectors.
• Develop and maintain visual inspection schedules.
• Communicate effectively with manufacturing and quality assurance to prioritize visual inspection schedules.
• Develop and maintain data trending reports from visual inspection data.
• Deliver engaging, informative, well-organized presentations with regards to recommendations based on visual inspection data.
• Develop and deliver training to visual inspectors.
• Review Visual Inspection Master Batch Records and Finished Product Batch Records.
• Participate in SQIRs, CAPAs, Deviation Investigations and Customer Complaint investigations with regards to visual inspection.
• Keep abreast of industry standards and trends with regards to visual inspection of
• components and finished product.
• Participate in visual inspection groups within organizations such as PDA.
• Train new hires as well as veteran employees.
• Document and communicate in upward/downward levels, professionally.

Full job description available during formal interview process.