Quality Control Operations - Analyst I

Primary Responsibilities

The successful candidate will support laboratory operations by performing analytical assays, maintaining compliance with quality standards, and contributing to the overall success of quality control activities.

Responsibilities

• Perform routine and non-routine analytical assays to support raw materials, in-process samples, product release, and stability studies following established SOPs.
• Maintain training records, adhere to testing schedules, and ensure timely completion of assignments to meet project timelines and quality metrics.
• Assist in laboratory operations, including equipment maintenance, inventory management, and preparation of reagents and samples.
• Accurately document experimental data and observations in compliance with GxP standards.
• Participate in the review of data and contribute to the revision and updating of controlled documents such as SOPs, work instructions, and test methods.
• Adhere to internal policies, SOPs, and regulatory standards (e.g., GMP, GLP, ICH guidelines) to maintain high levels of quality and compliance.
• Identify and suggest improvements to laboratory methods and processes to enhance efficiency and reliability.
• Collaborate with cross-functional teams to ensure seamless quality control operations.
• Pursue ongoing training to deepen expertise in analytical techniques and regulatory compliance.

Skills & Requirements

• Bachelor's degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related field.
• Familiarity with GMP/GLP-regulated laboratory environments; experience in pharmaceutical or biotechnology industries is a plus.
• Understanding of analytical techniques used in raw materials, in-process testing, release, and stability studies is preferred.
• Strong documentation skills with attention to detail and a commitment to quality and compliance.
• Basic awareness of regulatory guidelines relevant to pharmaceutical QC (e.g., GMP, GLP, ICH).
• Effective communication and teamwork skills with the ability to collaborate across functions.
• Ability to work under supervision and follow detailed instructions.