QC Chemist I​/II

The QC Chemist I/II performs analytical testing of raw materials, in-process materials, finished products, and stability samples using approved, compendial, validated, or internal test methods.
This position may be filled at either QC Chemist I or QC Chemist II based on a combination of relevant professional experience, education, demonstrated technical proficiency, level of independence, instrumentation expertise, and experience with pharmaceutical Quality Control responsibilities
. Placement will not be determined by years of experience or previous job title alone. QC Chemist I is intended for developing chemists capable of independently performing routine testing after qualification, while QC Chemist II is intended for experienced pharmaceutical laboratory professionals capable of handling complex testing, analytical troubleshooting, data review, investigations, and method-related activities with limited supervision.

• Perform analytical testing of raw materials, in-process samples, finished products, and stability samples using approved methods;
  Chemist I personnel primarily perform routine testing, while Chemist II personnel perform both routine and complex analyses requiring greater technical judgment.
• Operate analytical instrumentation including HPLC, UPLC, GC, UV-Vis, dissolution equipment, Karl Fischer titrators, pH meters, balances, and related laboratory equipment based on demonstrated training, qualification, and assigned level.
• Prepare and standardize samples, reference solutions, reagents, buffers, and mobile phases while documenting all laboratory activities accurately and contemporaneously in accordance with cGMP, ALCOA, and Data Integrity requirements.
• Evaluate analytical results against established specifications and acceptance criteria;
  Chemist I personnel identify and promptly
  * escalate* atypical or potential OOS/OOT results, while Chemist II personnel independently interpret complex data, identify trends, and review peer-generated analytical documentation.
• Support laboratory investigations, method verification, validation, transfer, and troubleshooting activities;
  Chemist II personnel are expected to independently execute assigned method activities, contribute to scientific root-cause analysis, and support deviations, CAPAs, and change controls.
• Perform assigned instrument calibrations, preventive maintenance, equipment readiness checks, and basic troubleshooting;
  Chemist II personnel also provide technical guidance to less experienced chemists and support improvements to laboratory procedures and processes.

• QC Chemist I:
  Typically requires 1–3 years of relevant professional analytical laboratory experience with a Bachelor’s degree. A candidate with a Master’s degree in Chemistry and no professional laboratory experience may also be considered for Level I based on demonstrated academic laboratory training and technical knowledge. A Bachelor’s degree without relevant professional laboratory experience will normally be considered at the QC Junior Chemist level.
• QC Chemist II
  :
  Typically requires 3–6 years of progressively responsible analytical experience in a cGMP-regulated pharmaceutical Quality Control laboratory, including demonstrated independence in analytical testing, data interpretation, instrument troubleshooting, and GMP documentation.

Final level placement will be based on the complete qualifications of the candidate, including the relevance and quality of experience, education, independent proficiency with applicable instrumentation, complexity of testing performed, cGMP knowledge, data-review experience, investigation involvement, and method verification, validation, or transfer experience. Meeting the stated number of years alone does not guarantee Level II placement.

• Bachelor’s degree in Chemistry, Pharmaceutical Sciences, or a closely related chemistry-based scientific discipline required.
• Master’s degree in Chemistry may substitute for prior professional experience when determining eligibility for QC Chemist I; an advanced degree alone does not qualify a candidate for QC Chemist II
  .

• QC…