Quality Control Technician

Job Overview

Perform basic, intermediate, or advanced quantitative and qualitative analyses of pharmaceutical components, in-process material, finished goods, and/or stability product. Depending on the department, some functions may not be applicable.

• Set‑up, adjustment, calibration and operation of laboratory equipment and instruments, including associated software.
• Preparation of solutions, solvents, and mobile phases.
• Accurate preparation, collection, weighing, and analysis of samples and reference standards, determining conformance to approved specification limits.
• Assist in basic investigations for out‑of‑specification/out‑of‑trend results.

Provide accurate and timely documentation of all procedures, calculations, and results.

• LIMS entry, approval, and data release of products.
• Use of analytical balances, HPLC, GC, KF Titrator, IR, UV, pH meter, volumetric glassware.
• Perform wet testing such as assay titrations, colorimetric tests, TLC, heavy metals, and sieves.
• Flexibility to work in other laboratories based on business need.
• Follow established procedures using own discretion and judgment.
• Identify/Research new lab supplies and order current lab supplies.
• Identify and implement cost‑saving opportunities.
• Sustain laboratory housekeeping and identify improvement opportunities.
• Complete hands‑on and electronic training.
• Participate and lead area huddles or shift meetings.
• Perform other duties as assigned.

• QC Tech I – Perform basic wet chemistry, preparation of reagents/solutions, and sample reconciliation following approved methods.
• QC Tech II – Experienced with some instrumentation and wet testing.
• QC Tech III – Expert in wet chemistry analysis and instrumentation analysis performed by laboratory; perform instrument maintenance and troubleshoot chromatography issues; trainer for proficiency areas; perform peer review, release of all products, participate in validations, and execute Gage R&R experiments; initiate and support investigations; identify method improvements and perform change controls; communicate technical information within lab and with other departments.

• Education – High School Diploma or equivalent required. Bachelor’s degree in Chemistry, Biology, or related science preferred;
  Associate’s degree with equivalent education, experience, and competencies accepted.
• Experience – Tech I:
  Classroom or previous work experience in a science related field. Tech II:
  Working knowledge of chemistry required. Tech III:
  Minimum 1–3 years of experience in a cGMP facility.
• Skills – Basic arithmetic, reading, writing, and speaking at a basic level; computer skills including Word, Excel, and database software; understanding of cGMP, SOP, and DEA regulations; problem‑solving of moderate difficulty; self‑motivated and initiative; teamwork; attention to detail; ability to learn technical concepts rapidly.

• Basic functions of arithmetic: add, subtract, multiply and divide all units of measure.
• Basic reading, writing and speaking at a basic level.
• Basic computer skills.
• Ability to understand and apply cGMP, SOP, and DEA regulations.
• Problem‑solving of moderate difficulty.
• Self‑motivated, demonstrates initiative, able to make good decisions under pressure.
• Performs well as part of a team.
• Attention to detail and accuracy.
• Ability to learn and apply technical concepts rapidly.

• Comply with company policies and procedures.
• Follow safe working practices.
• Participate in general site and departmental safety initiatives.

• Attention to Detail / Focus – Thorough and precise in accomplishing a task through concern for all areas involved; double‑checks accuracy and provides timely information.
• Listening – Practices attentive and active listening; accurately restates opinions of others.
• Consistent Process Follow – Accurately checks processes and follows established procedures.
• Problem Solving – Rigorously connects information, organizes divergent data, develops contingency plans.
• Analytical – Uses systematic approach; logical,…