Quality Control Analyst III

Responsibilities

• Perform complex testing and data evaluation, such as HPLC, ELISA, etc.
• Troubleshoot equipment issues promptly and communicate resolutions to management
• Participate or assist with test method validations
• Evaluate data for trends
• Support and/or investigate OOS events by performing thorough root cause analyses, assessing potential product impact, and implementing appropriate CAPAs
• Interact with outside departments including attending meetings, providing updates, etc.
• Cook up and order supplies, as necessary
• Enter data into relevant data management systems and perform tracking and trending of data
• Compile data and provide/present data summaries to management
• Utilize a thorough understanding of regulatory and compliance guidelines for the pharmaceutical industry
• Collaborate with cross-functional departments to coordinate testing, scheduling needs, and prioritization
• Lead departmental projects and participate in cross-functional teams, including continuous improvement initiatives and new customer project teams
• Lead the stability program, including management of test points, reporting of data, and investigations of out of specification or aberrant stability results

Requirements

• Bachelor's Degree in Chemistry or related field and 5+ years related work experience; OR Master’s Degree in Chemistry or related field and 3+ years related work experience; OR PhD in Chemistry or related field and 1+ years related work experience
• Experience working in cGMP or GLP pharmaceutical industry environment
• Excellent verbal and written communication skills, including the ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public
• Strong time management and organizational skills with the ability to multi-task and manage multiple projects independently
• Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations
• Ability to write reports, business correspondence, and procedures
• Knowledgeable in FDA GMPs (21 CFR, 211, 820, and/or 600); ISO 9001 and 13485 a plus