QC Analyst II

Aveva Drug Delivery Systems; Fort Lauderdale (FL); On-site; USD 52,000 - 90,000; Full time

Job summary

Aveva Drug Delivery Systems is seeking a QC Analyst to perform analytical testing on raw materials and components. The role involves validating methods, calibrating instruments, and ensuring compliance with SOPs and regulatory standards.

The position requires experience with GC, HPLC, UV methods, and knowledge of compendial methods. Collaboration with supervisors and training of new chemists are integral parts of the role.

Qualifications

• Bachelor's degree (B.S.) in chemistry or related field or;
• Master's degree (M.S.) in chemistry or related field
• Knowledge of statistical concepts and data interpretation
• Experience in testing of raw materials and related QC procedures
• Familiarity with FDA, cGMPs and SOPs

Responsibilities

• Performs testing of analytical assays, including HPLC, GC, UV testing for raw materials.
• Perform raw materials and components ID methods.
• Reviews laboratory data as assigned by Supervisor.
• Performs IQ/OQ of analytical instrumentation.
• Calibrates analytical instrumentation by standard protocol.
• Revises STPs and SOPs and Specifications.
• Assists the supervisor in training new chemists.
• Other general QC laboratory responsibilities as assigned.
• Operates in accordance with regulatory and safety requirements.
• Works as a team member to achieve outcomes.

Skills

Laboratory testing

Data analysis

Problem solving

Education

Bachelor's degree in chemistry or related field

Master's degree in chemistry or related field

Tools

GC

HPLC

Karl Fischer

FTIR

UV spectroscopy

Job description

DescriptionJob Summary: Performs analytical testing of raw materials, and components.

Job Responsabilities

• Performs testing of analytical assays, including HPLC, GC, UV testing for raw materials.
• Perform raw materials and components ID methods.
• Reviews laboratory data as assigned by Supervisor
• Perform testing following compendial methods (USP, EP, JP)
• Maintains proficiency with data acquisition systems
• Calibrates analytical instrumentation by standard protocol
• Revises STPs and SOPs and Specifications
• Assists the supervisor in training new chemists
• Perform method transfer or method verifications.
• Performs IQ/OQ of analytical instrumentation
• Troubleshoots instrumentation with guidance of Supervisor
• Other general QC laboratory responsibilities as assigned
• Support housekeeping and maintenance activities
• 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
• Knowledge, Skills and Abilities
• Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of algebra. Ability to apply concepts such as fractions, percentages, ratios, linear regression, and proportions to practical situations.
• 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.
• Experience in the testing of raw materials.
• Working knowledge of GC, HPLC, Karl Fisher, FTIR, UV spectroscopic methods, and compendial methods.
• Ability to read analyze, and interpret common scientific and technical journals, specifications, standard operating procedures, and standard testing procedures.
• Knowledge FDA, cGMPs, and SOPs
• Experience
• A minimum of two to five (2-5) years of QC laboratory experience (Bachelor’s degree)
• A minimum of two (2) years of QC laboratory experience (Master’s degree)