QC Analyst I - Analytical Testing & Transfer

Aveva Drug Delivery Systems; Town of Florida (NY); On-site; USD 65,000 - 90,000; Full time

Job summary

Aveva Drug Delivery Systems in the United States is seeking a QC Analyst to perform analytical testing of raw materials, components, standards, intermediates and finished products, supporting technology transfer and validations.

Responsibilities include release and stability testing, verification protocols, data review, instrument calibration, SOP writing, and training of analysts, while maintaining QC compliance and regulatory standards such as FDA/cGMP.

Qualifications

• BS in chemistry or related field.
• MS in chemistry or related field.
• PhD in chemistry or related field.
• Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, linear regression, and permutations.
• Ability to define problems, collect data, establish facts, and draw valid conclusions.
• Ability to read, analyze, and interpret scientific and technical literature and SOPs.
• Knowledge of FDA, cGMPs, and SOPs.

Responsibilities

• Supports release and stability testing for raw materials, components, standards, intermediate/finished products
• Prepares and executes verification protocols for in-house/compendia test methods
• Executes technology transfer protocols and assists in evaluations
• Analytical support to AD for qualification/validation of test methods
• Reviews laboratory work and approves data packages as designated by the Supervisor
• Maintains a heightened proficiency with data acquisition systems
• Execute methods for calibration of analytical instrumentation
• Writes and reviews STPs, SOPs, Specifications and technical reports
• Trains analysts on methods and instrumentation
• Independently troubleshoots instrumentation
• Maintains QC compliance systems with guidance of Supervisor
• Coordinates testing schedules and monitors status of sample testing as assigned by the Supervisor
• Works as a member of a team to achieve all outcomes
• Operates in accordance with our Code of Conduct and Business Ethics, and all established regulatory, compliance and safety requirements
• Performs all work in support of our Values: Collaboration, Courage, Perseverance, and Passion
• All other relevant duties as assigned

Skills

Analytical testing

Data analysis

cGMP compliance

Method development/validation

Instrument calibration

QA documentation

Statistical analysis

FDA knowledge

Education

B.S. in Chemistry

M.S. in Chemistry

Ph.D. in Chemistry

Job description

Aveva Drug Delivery Systems in the United States is seeking a QC Analyst to perform analytical testing of raw materials, components, standards, intermediates and finished products, supporting technology transfer and validations.

Responsibilities include release and stability testing, verification protocols, data review, instrument calibration, SOP writing, and training of analysts, while maintaining QC compliance and regulatory standards such as FDA/cGMP.