Sr. QC Analyst

Corden Pharma Colorado Boulder, CO, US, CO
$35 - $43Onsite

About The Position

Performs laboratory tests to determine chemical and physical characteristics or composition of solid and liquid materials for quality control, process control, or product development consistently and accurately. Displays ability to set up and follow procedures independently as directed. Maintains a high level of housekeeping. Displays initiative in completing training, and the ability to train others. Displays high level of attention to detail. Provides expert technical advice to customers as directed.

Requirements

  • Bachelor's Degree from a 4-year college or university in a related science area and 5 years of GMP experience in a Quality Lab.
  • Master’s Degree from a college or university and 2 years GMP experience in a Quality Lab; or 5 years of related experience in a Quality environment; or equivalent combination of education and experience.
  • Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals.
  • Ability to write routine reports and correspondence.
  • Ability to speak effectively before groups of customers or employees of the organization.
  • Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry.
  • Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
  • Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
  • Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
  • Highly developed analytical skills and knowledge of general or organic chemistry.
  • Specialized skills on non-routine methods.
  • Ability to demonstrate self-direction in the absence of immediate supervision.
  • Mechanical aptitude with lab equipment.
  • Advanced analytical data analysis with ability to detect errors.
  • Preform general lab duties.
  • Good communication and presentation skills.
  • Demonstrated problem-solving skills.
  • Commitment to QSHE Principles.
  • Ability to write and revise SOPs and Methods as directed.
  • Advanced understanding of laboratory software.
  • Review of analytical data.
  • Review and execution of method transfers and validations.
  • Ability to work 12 hour rotating shifts, night or day; weekends and holidays required.
  • Strong computer skills to include word processing, spreadsheets, e-mail, and database applications.

Responsibilities

  • Run routine and advanced analysis on non-routine samples.
  • Work with the Process Chemists and QC Chemists to reach solutions to unresolved problems and train new technicians.
  • Perform equipment calibration, titrant standardization, and standard validation as required.
  • Identify and correct problems with instruments in the QC Lab.
  • Identify and communicate problems and solutions related to process, procedure, and materials to QC Chemist.
  • Research and take corrective action on anomalous test results.
  • Maintain cleanliness and organization of lab by following safety, regulatory, and chemical hygiene policies, including GLPs and GMPs.
  • Effectively troubleshoot QC Lab instrumentation and methods.
  • Perform daily record keeping on SAP and LIMS, print labels, review certificates of analysis, and approve final product.
  • Gather and compile data for statistical process control and perform LIMS modification.
  • Peer review analytical data.
  • Responsible for properly managing the generation and accumulation of hazardous and non-hazardous waste.
  • Attend and participate in QC Team meetings.
  • Develop team skills.
  • Take ownership of our own actions and work to achieve the results and goals of the organization.
  • Act as Shift Lead in the absence of management.

Benefits

  • 401(k) matching - Corden Pharma will contribute 100% of the first 6% - 100% vested after 2 years of service
  • Accident Plan
  • Critical Illness Insurance
  • Dental Insurance
  • Disability Insurance
  • Employee Assistance Program
  • Flexible Spending Account
  • Health Insurance PPO/HSA
  • Hospital Indemnity Plan
  • ID Theft Protection
  • Life Insurance
  • Paid Parental Leave
  • Tuition Reimbursement
  • Wellness Program
  • Vacation – Three Weeks 1st Year
  • Vision Insurance
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