QC Analyst II

AVEVA DRUG DELIVERY SYSTEMS INC•Miramar, FL

1d•Onsite

About The Position

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.

Requirements

Bachelor's degree (B.S.) in chemistry or related field or
Master's degree (M.S.) in chemistry or related field or
Ph. D. degree in chemistry or related field
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
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)

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