Quality Control Chemist I

About the Role

The Quality Control Chemist I performs routine qualitative and quantitative analyses under appropriate supervision to support raw material qualification, in-process monitoring, stability studies, bulk intermediates, and finished product release. The role applies the scientific method and fundamental analytical chemistry skills while developing proficiency in chromatography, laboratory instrumentation, cGMP practices, and accurate documentation. This entry-level role follows approved procedures, maintains complete and traceable laboratory records, evaluates routine results for accuracy and abnormalities, and promptly communicates issues to supervision. The QC Chemist I supports investigations by providing factual data, participates in 5S and departmental initiatives, and collaborates professionally with Quality Assurance and other functions while continuing to build scientific knowledge and independence.

Key Responsibilities

• Perform routine testing of raw materials, in-process samples, intermediates, finished products, and stability samples using approved methods and in accordance with cGMP, GDP, and applicable compendial requirements.
• Prepare reagents, standards, and sample solutions accurately, with complete documentation and traceability.
• Perform wet chemistry analyses and operate chromatographic instrumentation, including HPLC and GC, with appropriate supervision; develop proficiency with non-chromatographic laboratory instruments.
• Perform assigned environmental monitoring activities, where applicable, and promptly escalate deviations or unusual results in accordance with procedures.
• Record analytical activities and results in laboratory notebooks and electronic systems, such as LIMS, in accordance with GDP and ALCOA+ principles.
• Support deviation, OOS, OOT, and laboratory investigations by providing accurate factual data and timely information to the investigator or supervisor.
• Follow approved analytical methods and equipment procedures; support method, equipment, or system qualification activities as assigned.
• Participate in 5S, laboratory organization, and other continuous improvement activities.
• Review own work for accuracy and completeness and seek guidance when results, calculations, or observations are unclear.
• Comply with site safety, EHS, PPE, and hazardous-material handling requirements and promptly report safety concerns and near misses.
• Maintain laboratory cleanliness, readiness, and compliance with approved procedures and cGMP expectations.
• Communicate testing status, issues, and accurate updates to supervision in a timely manner and interact professionally with Quality Assurance and other departments.
• Manage assigned tasks and deadlines with supervision, remain open to new initiatives, and complete additional duties or training assigned by QC leadership.

Requirements & Tech Stack

• Understanding of the scientific method and experience applying fundamental analytical chemistry principles and laboratory skills.
• Ability to follow written procedures accurately and maintain a clear, complete laboratory notebook and accurate data entries in compliance with GDP.
• Ability to assess routine situations, propose solutions, recognize the limits of assigned scope, and escalate issues appropriately.
• Understanding basic laboratory practices and GLP requirements, with willingness to develop knowledge of cGMP, GDP, ALCOA+, and USP testing expectations.
• Clear written and verbal communication skills, including timely reporting of issues and accurate status updates.
• Ability to manage one or more assigned tasks with supervision, meet deadlines, adapt to new initiatives, and contribute professionally to the QC team.

Qualifications

• Bachelor’s degree (B.S./B.A.) in Chemistry or a related scientific discipline with 1–3 years of relevant laboratory experience; or
• Master’s degree in Chemistry or a related scientific discipline with 0–1 year of relevant laboratory experience.

Preferred Qualifications

• Experience in a regulated pharmaceutical, OTC drug, cosmetic, medical device, or other GMP/GLP laboratory environment.
• Familiarity with LIMS or another laboratory information management system.
• Basic understanding of chromatographic concepts and experience with HPLC or GC through employment, internship, or academic laboratory work.
• Exposure to wet chemistry testing and non-chromatographic laboratory instrumentation.
• Awareness of USP testing requirements and experience reviewing analytical data for accuracy, abnormalities, or inconsistencies.
• Experience participating in 5S, laboratory organization, or continuous improvement activities.