Job Description
Job Description
The QC Chemist is responsible for performing routine and non-routine testing of bulk products and raw materials, making in-process adjustments to bulk as needed, and ensuring that all results are correctly documented to support product release and Certificate of Analysis (COA) issuance. This role also supports GMP compliance through housekeeping checks, documentation reviews, and equipment calibration.
Responsibilities
- Perform analytical and physical testing of bulk products (e.g., appearance, pH, viscosity, assay, specific gravity) according to approved methods and specifications.
- Make in-process adjustments to bulk batches under the guidance of QC/QA or Production (e.g., pH, viscosity, color, odor), document changes, and re-test as required for final approval.
- Collect and test raw material samples upon receipt (identity, purity, quality attributes), compare results against specifications, and release or reject materials.
- Prepare and/or verify Certificates of Analysis (COAs) for bulk products and raw materials, ensuring data accuracy, traceability, and proper review/approval.
- Maintain accurate and timely laboratory records (notebooks, worksheets, logbooks, electronic systems) in compliance with GMP and internal SOPs.
- Conduct routine housekeeping and 5S checks in the QC laboratory and adjacent areas; escalate and help close any issues related to cleanliness, organization, or safety.
- Support documentation review related to QC activities (test records, logbooks, analytical worksheets) for completeness and data integrity.
- Coordinate and/or perform calibration and verification of laboratory equipment (balances, pH meters, viscometers, thermometers, etc.), maintain calibration records, and ensure equipment is labeled and within calibration status.
- Assist with investigations, deviations, OOS/OOT results, and implementation of CAPAs related to laboratory testing or material quality.
- Support method transfer, method validation/verification, and implementation of new test procedures as needed.
- Participate in training of new QC staff on test methods, documentation practices, and GMP expectations.
- Promote a strong quality culture, reporting any observed non-conformities and suggesting improvements to procedures and systems.
- May be assigned other duties or tasks as needed or directed by management.
Qualifications
- Bachelor’s degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or related field.
- 1–3 years of experience in a QC laboratory (pharmaceutical, cosmetics, or related regulated industry preferred).
- Working knowledge of wet chemistry techniques and common lab instruments (pH meter, balance, viscometer, titrator, spectrophotometer, etc.).
- Familiarity with GMP, data integrity principles, and documentation practices.
- Strong attention to detail, good organizational skills, and ability to manage multiple priorities.
- Good communication skills and ability to work collaboratively with Production, QA, and other departments.
- Must be flexible to work from 6 am to 2:30 pm or 10 am to 6:30 pm.
- Ability to work with minimum supervision, along with working as part of a team.
- Computer skills in MS Word, Excel, and Google Docs are desirable.
- Must be able to lift up to 25 lbs