Quality Control Analyst , II or III

Job Overview

Curia is a global contract development and manufacturing organization (CDMO) with over 30 years of experience partnering with pharmaceutical and biotech companies to advance therapies from curiosity to cure and ultimately improve patients’ lives.

• Perform complex testing and data evaluation such as TGA and liquid/gas chromatography (UPLC), troubleshooting issues as needed.
• Participate in test method validations, evaluate data for trends, and support supervisors in OOS investigations and CAPA requirements.
• Coordinate testing performed at outside labs and raw materials, maintaining a detailed and accurate record of activities and results on paperwork.
• Execute, author, and review SOPs, reports, protocols, investigations, change controls, and data summaries, using basic risk assessment and root cause tools.
• Train upon and understand methods, equipment, and standard operating procedures; provide training to others as needed.
• Support equipment upkeep, prepare and order supplies, and enter data into relevant data management systems, performing tracking and trending of data as requested.
• Utilize a thorough understanding of regulatory and compliance guidelines for the pharmaceutical industry, interacting with other departments for testing needs and scheduling.
• May lead departmental projects, cross‑functional teams, and continuous improvement projects, and may lead stability program including management of test points, reporting of data, and investigations of out of specification results.

• Bachelor’s degree in Chemistry or related field.
• QC Analyst I: 0-2 year experience.
• QC Analyst II: 3-5 year experience.
• QC Analyst III: 5-7 year experience.

• Experience working in a cGMP or GLP pharmaceutical industry environment.

• Excellent verbal and written communication skills; ability to present information and respond to questions from managers, clients, customers and the general public.
• Ability to meet deadlines, work under pressure with limited supervision, and manage multiple projects independently.
• Strong analytical skills, including reading, analyzing and interpreting technical procedures and regulations.
• Proficient use of computer software including Microsoft Office Suite and instrument manufacture‑based systems.
• Knowledge of FDA GMPs (21 CFR 211, 820, 600), ISO 9001 and ISO 13485 a plus.

Regularly required to talk, hear, stand, walk, sit, use hands, reach, and handle objects. Occasionally required to climb, balance, stoop, kneel, crouch and crawl. May lift and/or move up to 10 pounds frequently and up to 25 pounds occasionally. Exposed to fumes or airborne particles, toxic or caustic chemicals, wet and/or humid conditions, moving mechanical parts, high or precarious places, risk of electrical shock, explosives, risk of radiation and vibration.

Noise level is usually moderate.

Curia is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Curia is an E‑Verify employer.