The person hired for the position of Quality Control Raw Material Group Lead will oversee the testing and release of Raw Materials and Hard Goods. The Quality Control Group Lead will support issue resolution and work to resolve technical or other product quality issues. The Quality Control Raw Material Group Lead is responsible for leading safety initiatives and coordinating training, while driving completion of new product and continuous improvement projects.This position requires the use of appropriate techniques and tools such as, Six Sigma, LEAN, and SPC, while demonstrating leadership in audits.
Job Responsibilities
• Oversee day-to-day operations associated with raw material and hard good testing, data review and batch release.
• Manage raw material testing sent to contract laboratories.
• Maintain Raw Material Reduced Testing documentation as applicable.
• Review and approve packaging component specifications as assigned.
• Initiate and lead investigations related to non-conformances and/or Out-Of-Specification / Out-of-Trend results, ensuring on-time closure per SOP requirements.
• Work cross functionally with Supply Chain and Production to agree on and meet material need-by dates
• Gather, report and present data related to Raw Materials to support annual Product Quality Reviews (PQR).
• Ensure world-class safety within the Quality Control Laboratory at the Northridge Facility.
• Ensure laboratory compliance to cGxPs and other relevant regulatory requirements.
• Provide cross-functional support to other QC Raw Material team as needed.
• Review and update lab documentation such as SOPs, worksheets, specifications, and methods to reflect current processes, etc.
• Perform and support qualification, calibration, and maintenance of quality control laboratory equipment
• Support introduction of new analytical techniques and equipment to the quality control laboratory
• Support Internal and External Audits as needed
• Mentor, support, and train Raw Material analysts.
• Ability to work flexible hours as needed to support production demands
• Work well in both team and individual environments
• Other duties as assigned
Requirements
• Bachelor’s degree in a science discipline from an accredited university
• Basic understanding of cGxPs
• Minimum 2+ years analytical testing experience
Preferred
• Bachelor’s degree or higher in Chemistry from an accredited university
• Testing experience within the pharmaceutical industry
• Strong background in QC Raw Material Analytical techniques, knowledge of compendial and non-compendial requirements and guidelines pertaining to raw material testing, and validation requirements.
• Experienced in leading technical lab investigations
• Demonstrated strong oral and written communication skills
• Demonstrated ability to lead technical teams