Quality Control Analyst II

Curia is a global contract development and manufacturing organization serving pharmaceutical and biotechnology companies. The Quality Control Analyst II performs routine and non-routine analytical chemistry testing on materials and products, and supports method development, transfers, validations, cleaning studies, investigations, equipment maintenance, and technical support for QC operations.

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
• Perform OOS investigations and lab deviation investigations
• 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

Preferred

• Experience working in cGMP or GLP pharmaceutical industry environment
• ISO 9001 and 13485 a plus
• cGMP Experience
• GLP Experience
• ISO 9001
• ISO 13485

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

Company

• Biologics and small molecule CDMO
• Albany, New York, USA
• https://curiaglobal.com/
• Founded in 1991
• 1001-5000 employees

Qualifications

• Bachelor's degree in Chemistry or related field
• Minimum 3-5 years' experience in pharmaceutical industry environment 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)
• Experience working in cGMP or GLP pharmaceutical industry environment
• ISO 9001 and 13485 a plus
• Minimum 3-5 years’ experience in pharmaceutical industry environment or equivalent combination of education and experience

Required skills

• Analytical chemistry, Analytical method development, Cleaning validation, Deviation and CAPA investigations, FDA GMPs (21 CFR), HPLC/GC chromatography, ISO 9001 and ISO 13485, Method qualification, transfer, and validation, Microsoft Office Suite, Out-of-specification (OOS) investigations, UPLC, Wet chemistry

Preferred skills

• Time management and organization, Written and verbal communication

Experience

• 3-5 years