Quality Analyst I — GMP QC & Documentation Onsite

Mark Cuban Cost Plus Drug Company; Dallas (TX); On-site; USD 39,000 - 48,000; Full time

Job summary

Mark Cuban Cost Plus Drug Company is seeking a Quality Analyst I to join the Quality Unit in Dallas, TX. The role is onsite and full-time, offering an hourly wage of $28.00 to $35.00.

Responsibilities include reviewing manufacturing events, documentation, and cGMP adherence, plus performing testing and environmental monitoring. Requires a Bachelor's degree in a scientific field and pharmaceutical experience.

Qualifications

• Bachelor's Degree in a Chemistry, Microbiology or related scientific field, or Equivalent years of directly related experience.
• Trained in lab testing processes and procedures.
• Knowledge of USP Sterile and Non-sterile Compounding requirements and FDA regulatory requirements (i.e. 21 CFR and FDA Guidance documents specific to Drug Manufacturing).

Responsibilities

• Completes incoming, in process and finished goods analytical testing to ensure all specifications are met.
• Draft, review and approve documentation for planned (change control, protocols, etc.) and unplanned (deviations, corrective maintenance, etc.) laboratory and manufacturing changes/events.
• Analyze/Review process data to assess trends and propose corrective/preventive actions.
• Performs Environmental Monitoring of production areas, including sample collection.
• Reviews line clearance and setup in production areas prior to the start of a new batch or operation.
• Provides Quality approval and acceptance, including the release of raw materials, components, and finished products/preparations.
• Provides oversight and guidance of MCCPMC staff to ensure cGMP adherence during compounded sterile preparations.
• Collects retention samples and monitors drug storage requirements.
• Completes other projects and duties as required and/or necessary.

Education

Bachelor's Degree in Chemistry, Microbiology or related scientific field, or Equivalent years of directly related experience

Job description

Mark Cuban Cost Plus Drug Company is seeking a Quality Analyst I to join the Quality Unit in Dallas, TX. The role is onsite and full-time, offering an hourly wage of $28.00 to $35.00.

Responsibilities include reviewing manufacturing events, documentation, and cGMP adherence, plus performing testing and environmental monitoring. Requires a Bachelor's degree in a scientific field and pharmaceutical experience.