POSITION: QC Chemist/Sr chemist
JOB DESCRIPTION:
· Perform sampling and testing of raw materials, packaging components, in-process samples, bulk products, finished products, purified water, and stability samples in accordance with approved specifications, USP/NF, FDA cGMP requirements, validated analytical methods, and Standard Operating Procedures (SOPs).
· Perform analytical testing using laboratory instruments including FTIR, UV-Visible Spectrophotometer, pH Meter, Viscometer, Balance, Karl Fischer Titrator, and other laboratory equipment as applicable.
· Review vendor Certificates of Analysis (COAs) and perform identification and compendial testing of incoming raw materials prior to release for manufacturing.
· Perform in-process and bulk product testing to support manufacturing operations and provide timely analytical results for production and batch disposition.
· Perform finished product testing for release, including assay, identification, related substances/impurities, dissolution, content uniformity, viscosity, pH, specific gravity, appearance, and other applicable quality attributes.
· Prepare, standardize, label, and maintain volumetric solutions, reagents, mobile phases, buffers, and reference standard solutions in accordance with approved procedures.
· Perform calibration, verification, routine maintenance, and performance qualification checks of laboratory instruments and equipment. Coordinate preventive maintenance and annual calibration activities with qualified external service providers when required.
· Review analytical data generated by other analysts for accuracy, completeness, compliance with specifications, calculations, chromatographic integration, and GMP documentation requirements.
· Assist laboratory deviations, Out-of-Specification (OOS), Out-of-Trend (OOT), atypical results, laboratory incidents, and instrument failures. Participate in root cause investigations and implementation of Corrective and Preventive Actions (CAPA).
· Support method validation, method verification, method transfer, cleaning validation, process validation, equipment qualification (IQ/OQ/PQ), and analytical method development activities.
· Perform stability testing in accordance with the approved stability program and assist in trending stability data to support product shelf-life.
· Support change controls, risk assessments, specification revisions, SOP revisions, laboratory investigations, annual product reviews, and continuous improvement initiatives.
· Ensure proper status labeling, storage, handling, and disposition of raw materials, in-process materials, finished products, reference standards, reagents, and retained samples.
· Maintain laboratory housekeeping and ensure compliance with Good Documentation Practices (GDP), Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP), and applicable safety procedures.
· Wear required Personal Protective Equipment (PPE) and comply with all Environmental Health and Safety (EHS) requirements.
· Participate in training programs and maintain qualification on analytical methods, laboratory equipment, SOPs, and cGMP requirements.
· Communicate analytical results, laboratory issues, and testing priorities effectively with Quality Assurance, Production, Research & Development, Supply Chain, and other cross-functional departments.
· Perform other laboratory and quality-related duties as assigned by the QC Manager or Quality Unit.
Benefits:
- Medical, Dental, and Vision
- 50k Life Insurance (paid by employer)
- All legal Employment Law considerations
- 401k
Pay: $55,000.00 - $85,000.00 per year
Benefits:
- 401(k)
- Dental insurance
- Health insurance
- Vision insurance
Application Question(s):
- Do you have 3-5 years experience in the lab?
- Do you live within a reasonable commute distance or willing to relocate?
- Do you know or will you in the future need sponsorship?
Work Location: In person
