Quality Control Analyst Jobs

About The Position

Requirements

• Bachelor's degree in Chemistry or related field
• Minimum 5-7 year’s pharmaceutical experience or equivalent combination of education and experience
• 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
• Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations
• Ability 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
• Ability to define problems, collect data, establish facts, and draw valid conclusions
• Ability 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

Nice To Haves

• Experience working in cGMP or GLP pharmaceutical industry environment

Responsibilities

• Perform complex testing and data evaluation such as TGA
• Perform 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.
• 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

Benefits

• Generous benefit options (eligible first day of employment)
• Paid training, vacation and holidays (vacation accrual begins on first day of employment)
• Career advancement opportunities
• Education reimbursement
• 401K program with matching contributions
• Learning platform