Quality Control Analyst III

About the role

The Quality Control Analyst III supports the manufacturing department and external customers by performing complex testing and data evaluation, participating in or assisting with test method validations, evaluating data for trends, and supporting supervisors in Out-of-Specification (OOS) investigations and completing Corrective Action Preventative Action (CAPA) requirements.

Responsibilities

• Perform complex testing and data evaluation such as TGAPerform complex Liquid/Gas Chromatography, UPLC, and other testing, and, as needed, troubleshoot issues
• Participate in or assist with test method validations
• Evaluate data for trends
• Support supervisors in OOS Investigations and complete CAPA requirements
• Interact with outside departments including attending meetings, providing updates, etc.
• Cook up and coordinate testing performed at outside testing labs, raw materials, etc.
• Maintain a detailed and accurate recording of activities and results on paperwork
• Execute, author, and review SOPs, reports, protocols, investigations, change controls, and data summaries
• Understand and use basic risk assessment and root cause tools
• Train upon and understand methods, equipment and standard operating procedures
• Provide training to others as needed
• Attend internal and external training on related subjects, including both intra- and inter-departmental cross-training on new techniques and procedures
• Support equipment upkeep and laboratory method trouble shooting
• Provide technical assistance during the shift for test method trouble shooting
• Prepare and order supplies, as necessary
• Enter data into relevant data management systems
• Perform tracking and trending of data as requested
• Compile data and provide data summaries to management
• Utilize a thorough understanding of regulatory and compliance guidelines for the pharmaceutical industry
• Interact with other departments within the company for testing needs and scheduling
• May lead departmental projects with the opportunity to participate in or lead cross-functional teams, including continuous improvement projects and new customer teams
• May lead 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
• Minimum 5-7 years' pharmaceutical experience or equivalent combination of education and experience

Qualifications

• 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
• Ability to meet deadlines and work under pressure with limited supervision
• 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 procedure manuals
• To apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations
• To apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis
• To define problems, collect data, establish facts, and draw valid conclusions
• To interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables
• Proficient use of computer software, including Microsoft Office Suite and instrument manufacture-based systems
• Knowledgeable in FDA GMPs (21 CFR, 211, 820, and/or 600); ISO 9001 and 13485 a plus

Physical requirements

• Frequent standing, walking, sitting, reaching, handling, feeling, and using hands to finger, handle, or feel
• Frequent stooping, kneeling, crouching, or crawling
• Frequent use of fine motor skills
• Frequent use of gross motor skills
• Frequent use of visual acuity

Work environment

• Frequent exposure to fumes or airborne particles and toxic or caustic chemicals
• Frequent exposure to wet and/or humid conditions
• Frequent exposure to moving mechanical parts
• Frequent exposure to high, precarious places
• Frequent exposure to risk of electrical shock
• Frequent exposure to risk of radiation and vibration
• Frequent exposure to noise levels in the work environment