Quality Control Analyst

Duration: 10 months contract (+Possibility of extension)

This position is onsite and will be primarily located in Norton, MA. There may be occasional responsibilities at a secondary location in Cambridge, MA.

The Quality Control Operations (QCO) LEQ Analyst III plays a crucial role in supporting the department's efforts to maintain the highest standards of quality and compliance from development through to commercialization. This position is responsible for supporting and executing laboratory equipment qualification activities in compliance with USP and applicable regulatory requirements. This role ensures laboratory instruments are fit for intended use throughout their lifecycle and supports data integrity, compliance, and continuous improvement within the laboratory quality system.

By ensuring these critical activities are executed with precision, the LEQ Analyst III significantly contributes to routine laboratory operations, thereby enhancing the overall efficiency and effectiveness of the QC functions.

• Perform and support laboratory equipment qualification activities, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) in accordance with USP .
• Classify laboratory instruments (Groups A, B, and
  
  C) and determine appropriate qualification strategies.
• Review and approve qualification protocols, test scripts, and reports.
• Support equipment lifecycle management, including calibration, maintenance, requalification, and change control.
• Review vendor documentation (URS, manuals, certificates) to support qualification and compliance.
• Investigate and document deviations, discrepancies, and out-of-tolerance events related to equipment performance.
• Ensure qualification activities comply with internal SOPs, cGMP, data integrity principles, and regulatory expectations (e.g., FDA, EMA).
• Collaborate with laboratory staff, quality assurance, validation, facilities, and vendors to resolve equipment-related issues.
• Maintain accurate and complete documentation in electronic quality systems.
• Support audits and inspections by providing qualification documentation and technical explanations as needed.
• Adhere to internal standards, policies, and SOPs, as well as regulatory and industry standards (e.g., GMP, GLP, ICH guidelines) to maintain the highest levels of quality and compliance.
• Actively participate in continuous improvement efforts by identifying and suggesting enhancements to laboratory processes, particularly those related to efficiency and reliability.
• Actively participate in continuous improvement initiatives aimed at enhancing QC processes and procedures, increasing laboratory efficiency and effectiveness.

• B.S. in chemistry, biology, or biochemistry, or related scientific field ;
• Pharmaceutical/Biotech industry experience with 6-10 years in a GMP Quality Control function or equivalent, relevant industry experience
• Hands-on experience with laboratory equipment qualification in a regulated environment.
• Strong working knowledge of USP and laboratory instrument lifecycle management.
• Familiarity with cGMP, GLP, and data integrity requirements.
• Experience with common laboratory instruments (e.g., HPLC, GC, balances, dissolution, UV/Vis, pH meters, spectrometers).
• Ability to write clear, compliant technical documentation.
• Strong organizational skills with the ability to manage multiple tasks simultaneously and autonomously
• Excellent communication and teamwork abilities, capable of working effectively in a collaborative environment
• Experience in pharmaceutical, biotech, or contract testing laboratory environments.
• Exposure to computerized systems validation (CSV) as it relates to laboratory instruments.
• Familiarity with calibration and maintenance programs.
• Experience supporting regulatory inspections or internal audits.