Quality Control Analyst

Job Description

Job Description

Quality Control Analyst

Job Description

The Quality Control Analyst performs physical property testing and wet chemistry testing on raw materials, in-process samples, and finished products, and progressively assumes responsibility for a full range of analytical testing, including chromatographic methods. This role prioritizes daily sample testing in a high-throughput environment, ensures the accuracy and completeness of laboratory and compounding records, and supports investigations into out-of-specification and out-of-trend results as well as customer complaints.

The analyst works closely with production, engineering, and quality teams to maintain compliance with Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP) while contributing to continuous improvement of laboratory methods, systems, and processes.

Responsibilities

• Perform laboratory analysis on incoming raw materials, in-process samples, and finished products according to established procedures, including physical property testing and wet chemistry methods such as viscosity, pH, and total organic carbon (TOC) for water testing.
• Conduct analytical testing using chromatographic techniques, including GC and HPLC, and become proficient in routine operation, integration, and result calculations for these instruments.
• Prioritize and execute daily sample testing to support bulk formula batches and line samples, ensuring timely turnaround in a high-throughput laboratory environment.
• Prepare samples for chromatographic analysis, including preparation of standard and reagent solutions in accordance with laboratory protocols.
• Access, input, and retrieve data from the Laboratory Information Management System (LIMS) to manage sample information, test results, and product disposition.
• Review compounding and laboratory records for accuracy and completeness, ensuring compliance with Good Documentation Practices (GDP) and Good Manufacturing Practices (GMP).
• Disposition raw materials, in-process samples, and finished products for use or sale based on test results and established specifications.
• Document deviations in performance or results that are not anticipated or indicated in test procedures, and communicate findings to appropriate quality personnel.
• Assist with investigations of out-of-specification (OOS) and out-of-trend (OOT) results, as well as customer complaints, by performing additional testing, data review, and documentation as required.
• Support method development protocols by conducting requisite testing, documenting results, and providing feedback on method performance.
• Assist with instrument qualification and validation activities, including IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification), as well as calibration tasks.
• Participate in method transfer protocols by performing comparative testing and ensuring methods are implemented consistently across laboratories or sites.
• Assist with annual and new supplier validation protocols, including sample transfer, testing, and documentation to qualify new materials or suppliers.
• Contribute to the creation, review, and revision of Standard Operating Procedures (SOPs) to ensure laboratory practices are clearly defined and up to date.
• Support stability studies by following stability protocols, performing scheduled testing, and documenting results in accordance with regulatory and internal requirements.
• Assist with ordering laboratory supplies and services to ensure adequate inventory and proper functioning of the laboratory.
• Support contract manufacturing workflows by performing required testing, documentation, and communication related to contract-produced materials or products.
• Perform routine instrument maintenance and assist with troubleshooting laboratory equipment to minimize downtime and ensure data integrity.
• Handle laboratory clean-up and housekeeping duties, including proper waste disposal and glassware washing, to maintain a safe and orderly work environment.
• Coordinate information flow within the laboratory and with internal customers, including production, mechanics, engineers, and quality assurance, to ensure clear communication and smooth operations.
• Collaborate with teammates across shifts to effectively "pass the baton" by communicating ongoing work, issues, and priorities to ensure continuity of testing and investigations.
• Work independently with minimal oversight, demonstrating strong problem-solving skills and escalating issues appropriately when they exceed individual authority or expertise.

Essential Skills

• Bachelor's degree minimum in Chemistry preferred, or in Biochemistry, Biolo