QC Analyst I

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

Description

Job Summary:

Performs analytical testing of raw materials, components, standards, intermediate/finished products. Responsible for testing involved with technology transfer from qualified laboratories on or off site to QC Miramar. Participates in testing to support Analytical Development method validations.

Job 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 heighten 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

Qualifications

• Education


• Bachelor's degree (B.S.) in chemistry or related field or;


• Master's degree (M.S.) in chemistry or related field


• Ph. D. degree in chemistry or related field


• Knowledge, Skills and Abilities


• Ability to apply advances mathematical concepts such as exponents, logarithms, quadratic equations, linear regression, and permutations. Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, and correlation techniques..


• 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.


• Ability to read, analyze, and interpret common scientific and technical journals, specifications, standard operating procedures, and standard testing procedures. Ability to write presentations and articles that conform to prescribed style and form. Ability to effectively present information to middle management.


• Knowledge FDA, cGMPs, and SOPs


• Experience


• A minimum of five to seven (5)-7 years of QC laboratory experience (Bachelor’s degree)


• A minimum of two to five (2 -5) years of QC laboratory experience (Master’s degree)


• A minimum of two (2) years lab experience (Ph. D. degree)