Quality Control Chemist

Primary Responsibilities

• Conduct testing of finished products, perform environmental monitoring, and carry out sterility quality control evaluations, documenting and reporting results accurately.
• Identify and escalate any non-conformances or deviations, managing these quality issues in accordance with established procedures.
• Assist with investigations related to deviations, OOS/OOT/OOE events, CAPA follow-ups, and implementation, as well as participate in Change Control activities including updating procedures and forms.
• Participate in required qualification or validation projects as assigned.
• Complete all mandatory training programs on schedule, covering SOPs, aseptic techniques, gowning protocols, testing methods, specifications, and health, safety, and environmental (HSE) requirements for the role.
• Prepare and maintain relevant documentation, forms, and records, such as analytical batch records, in alignment with Good Documentation Practices.
• Provide support during internal and external audits or inspections, as needed.

Required Qualifications

• Education: Bachelor’s degree in a relevant scientific field such as Microbiology or Chemistry.
• Experience: 0–2 years in a cGMP or aseptic manufacturing environment preferred.
• Knowledge of cGMP regulations and FDA guidance relevant to QC testing, environmental monitoring, and aseptic techniques.
• Hands-on experience with microbiological testing, method verification, routine QC assays, and environmental monitoring; understanding of method and equipment validation principles preferred.
• Familiarity with HPLC techniques is required.
• Ability to analyze and interpret test data and translate it into technical documentation.
• Foundational understanding of aseptic principles and techniques.
• Experience in quality control sampling and testing.
• General knowledge of health, safety, and environmental protocols.