Quality Control Analyst III

Job Description

Job Summary:

• 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 <1058> 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.
• This position is onsite and will be primarily located in Norton, MA.
• There may be occasional responsibilities at a secondary location in Cambridge, MA.

Duties and Responsibilities:

• Perform and support laboratory equipment qualification activities, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) in accordance with USP <1058>.
• 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.

Qualifications:

• 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.
• Experience supporting regulatory inspections or internal audits.
• Experience in pharmaceutical, biotech, or contract testing laboratory environments.
• Experience with common laboratory instruments (e.g., HPLC, GC, balances, dissolution, UV/Vis, pH meters, spectrometers).

Knowledge, Skills and Abilities:

• Strong working knowledge of USP <1058> and laboratory instrument lifecycle management.
• Familiarity with cGMP, GLP, and data integrity requirements.
• 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.
• Exposure to computerized systems validation (CSV) as it relates to laboratory instruments.
• Familiarity with calibration and maintenance programs.