Quality Control Analyst III

$80,000 - $90,000/Yr

Aveva Drug Delivery Systems - Miramar, FL

posted 4 months ago

Full-time - Mid Level
Miramar, FL
Chemical Manufacturing

About the position

The Quality Control Analyst III position at Aveva Drug Delivery Systems involves performing analytical testing of raw materials, components, standards, and intermediate/finished products. The role is critical in ensuring the quality and compliance of products through rigorous testing and validation processes. The analyst will be responsible for supporting release and stability testing, preparing and executing verification protocols for in-house and compendia test methods, and executing technology transfer protocols. This position also requires participation in testing to support Analytical Development method validations, which is essential for maintaining the integrity of the quality control processes. In addition to testing responsibilities, the Quality Control Analyst III will review laboratory work and approve data packages as designated by the Supervisor. The role demands a high level of proficiency with data acquisition systems and the execution of methods for the calibration of analytical instrumentation. The analyst will also be responsible for writing and reviewing Standard Test Procedures (STPs), Standard Operating Procedures (SOPs), specifications, and technical reports. Training analysts on methods and instrumentation is another key responsibility, along with independently troubleshooting instrumentation issues. The position requires maintaining QC compliance systems under the guidance of the Supervisor and coordinating testing schedules while monitoring the status of sample testing. The Quality Control Analyst III will work collaboratively as part of a team to achieve all outcomes, adhering to the company's Code of Conduct and Business Ethics, as well as established regulatory, compliance, and safety requirements. The role is integral to supporting the company's values of collaboration, courage, perseverance, and passion, and may include other relevant duties as assigned.

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
  • Provides analytical support to Analytical Development for qualification/validation of test methods
  • Reviews laboratory work and approves data packages as designated by the Supervisor
  • Maintains proficiency with data acquisition systems; executes 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 the Code of Conduct and Business Ethics, and all established regulatory, compliance and safety requirements
  • Performs all work in support of the company's values: Collaboration, Courage, Perseverance, and Passion
  • Performs all other relevant duties as assigned

Requirements

  • 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
  • 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)
  • Knowledge of FDA, cGMPs, and SOPs
  • Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, linear regression, and permutations
  • Ability to apply mathematical operations to tasks such 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

Benefits

  • 401(k)
  • 401(k) matching
  • Dental insurance
  • Health insurance
  • Life insurance
  • Paid time off
  • Vision insurance
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