Quality Assurance Engineer

Job Responsibilities

• Reviews and approves Investigations for product quality deviations.
• Reviews validation and qualification documents.
• Becomes Subject matter expert for company product line, production equipment, batch records and relevant SOP’s.
• Reviews and analyzes documents and data such as batch records, lab testing, finished product material statuses so as to support completion of the investigation process.
• Serves as an investigation team leader so as to assess impact on product quality and validation status.
• Recommends and monitors improvements in manufacturing and control systems including corrective and preventative actions (CAPA).
• Works together with multiple departments to troubleshoot the production processes and identify process improvement opportunities.
• Ensures compliance with GMP’s.
• Provides training and mentoring to colleagues performing investigations.
• Writes/revises SOPs relevant to the position’s responsibilities.
• Assesses / approves change controls related to production activities.
• Ensures compliance with all Company policies and procedures including safety rules and regulations.

Qualifications

• A Bachelor’s degree in Engineering or Life Sciences from an accredited college or university with a minimum of 5 - 8 years experience.
• A Master’s degree and 3-5 years of experience in a cGMP regulated manufacturing environment or an equivalent combination of training and experience is required.
• Preferred Bachelor’s degree (B.S.) in chemistry or related field with at least 5-8 years of experience in pharmaceutical analytical laboratory with transdermal laboratory experience, or Master’s degree (M.S.) with at least 3-5 years of experience.