Quality Control Analyst , II or III

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

This is a Salary Non
-Exempt Role (eligible for payment of overtime in accordance with Fair Labor Standards Act)

Curia is a global contract development and manufacturing organization (CDMO) with over 30 years of experience partnering with pharmaceutical and biotech companies to provide life‑saving treatments to patients. At Curia, we are on a mission to advance our customers’ therapies from curiosity to cure and ultimately to improve patients’ lives.

• Generous benefit options
• Paid training, vacation and holidays
• 401k program
• And more!

• 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
• 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
• 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

• Perform all GMP related documentation in compliance with ALCOA and good documentation practices as defined by site SOP’s.
• Strict compliance with all cGMP documents

SOP’s, Batch records, protocols, change controls, controlled forms, etc.

• Ensure all cGMP applicable training is kept current

Do not perform any cGMP task for which have not received appropriate training

• Escalate any cGMP concerns to Supervisors and to Quality Department as needed
• Perform job functions in compliance with applicable US FDA regulations and current Good Manufacturing Practices.

Required

Bachelor's degree in Chemistry or related field

QC Analyst I: 0-2 Year's Experience

QC Analyst II: 3-5 Year's Experience

QC Analyst III: 5-7 Year's 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
• 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…