Quality Control Analyst III

Job Description

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.

Education and Experience:

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

Knowledge, Skills and Abilities:

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

Tech/Tools:

• LIMS, Veeva.
• Empower/HPLC (nice to have).
• CMMS/Infor (Infor/EMMS).

Interviews:

• 2 rounds: 1) 1×1 manager (virtual), 2) panel (virtual or onsite).