Quality Control Analyst

Job Title: Quality Control Analyst

Job Description

The Quality Control Analyst performs critical testing on raw materials, environmental and utility samples, validation samples, and manufactured materials to ensure they meet defined quality requirements. This role reviews and documents test results in accordance with applicable regulatory, corporate, and data integrity standards, and may support method validation and method transfer activities within a cGMP pharmaceutical laboratory environment.

Responsibilities

• Perform routine and non-routine testing on raw materials, environmental samples, utilities, validation samples, and manufactured materials in accordance with approved SOPs, protocols, and cGMP requirements.
• Execute microbiological assays such as bioburden, endotoxin, and sterility testing, ensuring accurate, reliable, and timely results.
• Ensure all testing activities comply with applicable legal, health and safety, and regulatory requirements, as well as internal quality policies and procedures.
• Accurately document all laboratory work, calculations, observations, and results in approved formats, ensuring data integrity and traceability.
• Review test data and results for accuracy, completeness, and compliance with specifications before reporting.
• Author and contribute to laboratory investigations and invalid assay assessments, including root cause analysis and implementation of corrective and preventive actions as needed.
• Develop, draft, and maintain standard operating procedures (SOPs) for assigned assays, instruments, and laboratory processes.
• Develop and maintain expertise in assigned assays, analytical methods, and laboratory techniques, and apply this expertise to troubleshoot issues and optimize performance.
• Support method validation and method transfer activities by performing required testing, documenting results, and following validation protocols.
• Collaborate with cross-functional teams, including environmental monitoring and manufacturing, to support routine operations and special projects.
• Follow all laboratory safety procedures, including proper handling of chemicals, biological materials, and equipment.
• Use Laboratory Information Management Systems (LIMS) and other electronic systems to enter, track, and retrieve test data, as applicable.
• Participate in training activities and maintain up-to-date knowledge of GMPs, data integrity expectations, and analytical methodologies.
• Perform shift work as required to support laboratory and manufacturing operations, including potential off-shift, weekend, or holiday coverage.

Essential Skills

• Demonstrated experience performing laboratory testing in accordance with SOPs and protocols, with strong attention to detail and accuracy.
• Knowledge of quality control principles and practices in a laboratory setting.
• Understanding of cGMP principles and regulatory expectations in a pharmaceutical or similar regulated environment.
• Ability to perform microbiological techniques such as bioburden, endotoxin, and sterility testing or similar assays.
• Ability to develop and follow standard operating procedures and laboratory protocols.
• Strong documentation skills with a clear understanding of data integrity requirements.
• Ability to author and contribute to laboratory investigations and invalid assay assessments.
• Working knowledge of laboratory safety practices and regulations.
• Effective communication skills for documenting results and collaborating with cross-functional teams.
• Ability to work shift schedules as needed to support operations.

Additional Skills & Qualifications

• Degree in Biology or Microbiology is highly preferred.
• Experience with environmental monitoring in a pharmaceutical manufacturing environment is a strong plus.
• Experience working in an analytical testing laboratory, either in an academic or industry setting, is beneficial.
• Experience working in a cGMP pharmaceutical laboratory is advantageous.
• Familiarity with Laboratory Information Management Systems (LIMS) is a plus.
• Hands-on experience performing bioburden, endotoxin, and sterility testing is highly desirable.
• Intermediate knowledge of GMPs, safety regulations, and data integrity principles is preferred.
• Intermediate knowledge of analytical methods and related laboratory instrumentation is beneficial.
• Prior exposure to or collaboration with environmental monitoring teams is an asset.
• Ability to adapt to evolving procedures and support method validation and transfer activities.

Work Environment

This role operates in a regulated pharmaceutical laboratory environment that follows cGMP, safety, and data integrity standards. The position involves working with microbiological and analytical methods, including bioburden, endotoxin, and sterility testing, as well as handling raw materials, environmental and utility samples, and manufactured products. Work is performed using standard laboratory equipment, analytical instruments, an…