Quality Control Analyst II

About the role

The Quality Control Analyst II is responsible for performing routine and non-routine analytical chemistry assays of raw materials, in-process samples, finished APIs, and stability samples. This role also participates in special projects, method development/transfers and cleaning study qualifications.

Responsibilities

• Perform analytical testing for incoming, in-process and final products, and stability samples using equipment such as balances, pipettes, pH meter, UV/Visible spectrophotometer, Total Organic Carbon analyzer, etc.
• Perform chromatography (HPLC/GC, UPLC) with minimal qualification and training, wet chemistry assays, analytical chemistry assays, HPLC, GC, IR, UV, etc. and raw material testing and/or sampling
• Back up for QC analytical instrument maintenance and calibration
• Perform QC general laboratory equipment maintenance, laboratory housekeeping and preparation of the laboratory for audits
• Perform or assist with QC method qualifications, transfers and validations
• Perform QC method development
• Provide technical support for shift analysts
• Perform cleaning validation studies
• Assist with the evaluation of new equipment and processes
• Assist in the review of QC data and provide summaries to management as needed
• Assist QC Management, as needed, in the completion of OOS, deviations, and CAPAs investigations for QC
• Backup for QC analytical sample receipt for internal testing, outside laboratory testing, login, processing, shipment, tracking, distribution of test results, and closure

Requirements

• Bachelor’s degree in Chemistry or related field
• Minimum 3-5 years’ experience in pharmaceutical industry environment or equivalent combination of education and experience

Qualifications

• Preferred Experience working in cGMP or GLP pharmaceutical industry environment
• Knowledgeable in FDA GMPs (21 CFR, 211, 820, and/or 600); ISO 9001 and 13485 a plus

Skills and Abilities

• 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, establish facts, and draw valid conclusions
• Knowledgeable in FDA GMPs (21 CFR, 211, 820, and/or 600); ISO 9001 and 13485 a plus

Physical Requirements

• Regularly stand; walk; or sit
• Use hands to finger, handle, or feel
• Talk or hear
• Reach with hands and arms
• Climb or balance
• Stoop, kneel, crouch, or crawl
• Lift and/or move up to 50 pounds

Work Environment

• Potential exposure to fumes or airborne particles and toxic or caustic chemicals (wearing proper Personal Protective Equipment will be required in these situations)
• Exposure to wet and/or humid conditions
• Moving mechanical parts
• High, precarious places
• Outside weather conditions
• Risk of electrical shock (always being aware of one’s environment and taking proper precautions is required)
• Moderate noise level in the work environment
• Exposure to hazardous waste for treatment, storage and disposal

Pay Range

$67,000-$83,800