Job at a glance
Job Title: Night Shift Quality Lab Technician Job Description The Quality Lab Technician plays a key role in an OTC drug manufacturing laboratory by performing analytical testing on raw materials, in-process samples, and finished products. This role supports quality control activities, including laboratory investigations and analytical method transfers, while adhering to cGMP, USP, and regulatory requirements.
The technician collaborates closely with QC chemists, microbiologists, and other lab staff to ensure accurate results, reliable data, and consistent product quality. Responsibilities Perform raw material, in-process, and release testing using a range of analytical techniques such as UV-Vis, IR, HPLC, GC, AA, titrations, viscosity analysis, and other wet chemistry methods. Conduct analytical testing and support analytical method transfers in an OTC drug manufacturing laboratory.
Follow cGMP, USP, and 21 CFR 210/211 requirements for all laboratory testing activities. Participate in out-of-specification (OOS) and other laboratory investigations, including root cause analysis and data review. Apply technical knowledge of chromatography and bench chemistry to perform and interpret tests accurately. Use computer systems effectively, including Word, Excel, and laboratory information management systems (LIMS) where applicable.
Apply basic statistical concepts to compare data trends and evaluate test results. Verify numbers, words, and alphanumeric combinations across multiple documents and systems to ensure data integrity. Communicate clearly and professionally in both written and verbal form with team members and cross-functional partners. Collaborate with microbiologists, QC chemists, and other lab technicians to support team goals and maintain a cohesive laboratory environment.
Organize daily workload, prioritize tasks, and follow up on open items to meet testing deadlines and project timelines. Handle multiple tasks and projects simultaneously while maintaining accuracy and compliance. Follow verbal and written instructions, standard operating procedures (SOPs), and company policies consistently. Participate in training activities, including HR modules, learning SOPs, and shadowing team members during onboarding.
Support preparation for regulatory inspections and FDA audits by maintaining documentation and laboratory practices in an audit-ready state. Perform additional tasks assigned by the QC Supervisor or quality leadership in support of laboratory operations. Essential Skills Bachelor of Science or Bachelor of Arts degree in Chemistry or a related scientific field; a four-year scientific degree is required, with a preference for a degree in Chemistry.
Experience with HPLC and GC techniques in a laboratory setting. Hands-on experience with analytical chemistry and wet chemistry methods, including titrations and chromatography. Working knowledge of cGMPs as applicable to a laboratory environment. Ability to follow USP and 21 CFR 210/211 requirements for laboratory testing. Strong technical knowledge of chromatography and bench chemistry. Proficiency with Microsoft Word and Excel.
Ability to apply basic statistics to laboratory data and compare data trends. Excellent written and verbal communication skills in English. Strong problem-solving skills, including root cause analysis in a quality or laboratory context. Ability to read, write, and understand English and follow verbal and written instructions. Attention to detail with the ability to verify numbers, words, and alphanumeric combinations across multiple mediums.
Effective interpersonal and team-building skills to work productively within a laboratory team. Excellent organizational, prioritizing, and follow-up skills. Ability to manage multiple tasks and projects simultaneously. Willingness to work occasional off-shift hours, overtime, and some weekends as needed. Additional Skills & Qualifications Experience in OTC, pharmaceutical, or food and beverage testing enviro