Quality Control Analyst

Description

Position Summary:

• We are seeking a detail-oriented and motivated Quality Control Analyst I to join a dynamic laboratory team.
• This entry-level position is responsible for performing quality control testing of raw materials, in-process samples, finished products, and stability samples in compliance with cGMP and internal standards.
• The ideal candidate has a strong science background, laboratory experience (academic or professional), and a commitment to quality and accuracy.

Key Responsibilities:

• Perform routine analytical and microbiological testing on various sample types using standard laboratory instrumentation and techniques (e.g., HPLC, GC, UV-Vis, pH, FTIR).
• Conduct environmental monitoring and water sampling in cleanroom and production areas as required.
• Accurately document test results and laboratory observations in accordance with Good Documentation Practices (GDP).
• Assist in investigation of out-of-specification (OOS) or atypical results by gathering data and supporting root cause analysis.
• Maintain laboratory equipment and ensure calibration and preventive maintenance are up to date.
• Follow all safety procedures and maintain a clean, organized, and compliant laboratory environment.
• Collaborate with team members and communicate test results to relevant departments.
• Participate in quality and compliance training sessions as required.

Qualifications:

• Bachelor’s degree in Chemistry, Biology, Microbiology, or a related life sciences discipline.
• 0–2 years of experience in a laboratory setting (internship, academic, or professional).
• Basic understanding of analytical techniques and laboratory safety procedures.
• Familiarity with Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs) is preferred.
• Strong attention to detail and ability to work both independently and in a team environment.
• Proficiency in Microsoft Office (Word, Excel, Outlook).

Preferred Skills:

• Hands-on experience with analytical instruments (e.g., HPLC, Karl Fischer, FTIR).
• Experience working in a regulated environment (FDA, USP, ICH guidelines).
• Excellent documentation and organizational skills.