Quality Control Analyst III

Curia; City of Rensselaer (NY); On-site; USD 74,000 - 92,000; Full time

Job summary

Curia in Rensselaer, NY is seeking a Quality Control Analyst III to support manufacturing and external customers. The role involves testing raw materials, in-process, end product, and stability samples, with emphasis on data evaluation and method validation.

The candidate will perform LC/UPLC testing, contribute to CAPA and investigations, and ensure accurate record-keeping while collaborating with multiple departments. Strong knowledge of GMPs and data management is required.

Qualifications

• Bachelor's degree in Chemistry or related field.
• Minimum 5-7 year’s pharmaceutical experience or equivalent combination of education and experience.

Responsibilities

• Perform complex testing and data evaluation (e.g., TGA, LC/UPLC).
• Develop and validate test methods; review data for trends.
• Support OOS investigations and CAPA requirements.
• Enter data and generate data summaries for management.
• Train others and assist with cross-functional projects.

Skills

TGA

Liquid Chromatography

UPLC

Data analysis

Regulatory knowledge

Communication skills

Problem solving

Microsoft Office

Education

Bachelor's degree in Chemistry

Tools

Data management systems

Laboratory information management systems

Job description

Quality Control Analyst III in Rensselaer, NY - Days

Build your future at Curia, where our work has the power to save lives.

Position Overview

The Quality Control Analyst III is responsible for supporting the manufacturing department and external customers. Routine functions include testing of raw materials, in-process, end product, and stability samples.

Essential Job Duties

• 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

Education, Experience, Certification And Licensures Required

• Bachelor's degree in Chemistry or related field
• Minimum 5-7 year’s pharmaceutical experience or equivalent combination of education and experience

Preferred

• Experience working in cGMP or GLP pharmaceutical industry environment

Knowledge, 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, 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

Physical Requirements

While performing the duties of this Job, the employee is regularly required to talk or hear. The employee is frequently required to stand; walk; or sit; use hands to finger, handle, or feel and reach with hands and arms. The employee is occasionally required to climb or balance; stoop, kneel, crouch, or crawl and taste or smell. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.

Work Environment

While performing the duties of this Job, the employee is frequently exposed to fumes or airborne particles and toxic or caustic chemicals. The employee is occasionally exposed to wet and/or humid conditions; moving mechanical parts; high, precarious places; risk of electrical shock; explosives; risk of radiation and vibration. The noise level in the work environment is usually moderate.

Pay Range: $74,000 - $92,000

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, protected veteran status or disability. Curia is an E-Verify employer.