QA Supervisor at Adexen

Responsibilities

• To plan, organize, and supervise the activities of auditing, in-process inspection in manufacturing and packaging, and quality assurance administration to ensure regulatory compliance.
• Comprehend, maintain, and promote compliance in a regulated pharmaceutical manufacturing environment, ensuring product integrity, safety, and compliance with standards.
• Plan and supervise the daily activities of the quality assurance operation and inspectors, to ensure work is completed in a timely and accurate manner.
• Train, coach, and mentor QA personnel. Ensure training records are complete and accurate.
• Be proficient in all areas of manufacturing and packaging inspection process, including in-process QA, line inspection, label operation, incoming inspection, and expiration date assignment. Perform these duties as needed and directed by QA Management.
• Review batch records for accuracy and completeness for product disposition. Ensure that corrections are made in a timely manner.
• Possess a working knowledge of statistical based sampling plans and their application.
• Write Exception reports and provide information needed to investigate, document, and close Exceptions. Participate in non-compliance and customer complaint investigations.
• Quarantine and complete documentation for non-conforming materials. Ensure security of components and products in controlled access areas.
• Create and revise SOPs and Work Instructions. Track and trend metrics.
• Perform other duties as required.

Desired Skills and Experience

• Minimum Bachelor Degree. Master's Degree preferred or an equivalent combination of education and experience.
• 3+ years of QA experience in a manufacturing environment.
• Supervisory skills and experience.
• Ability to perform the physical tasks associated with sampling and inspecting.
• Highly organized, reliable, and detailed oriented.
• Must be a self-starter with critical thinking skills and able to multi-task and prioritize effectively.
• Excellent verbal and written communication skills to execute documentation and interact successfully with other departments.
• Computer skills including using MS Word and Excel.
• Flexibility to work on first or second shift if necessary, but predominantly the shift to which assigned.