QC Analyst III

Job Responsibilities:

• Perform tests for In-Process, Lot Release, and Stability studies.
• Support Utility and HVAC monitoring and sampling throughout the facility.
• Review assay results and ensure they meet required standards.
• Train team members and provide technical guidance.
• Write Quality Records including Deviations, CAPA, Change Control, and Test Methods.
• Manage projects, including method transfers, new instruments, and method qualifications.
• Utilize Microsoft Suites (Word, Excel, PowerPoint) for documentation and reporting.
• Work with Laboratory computer systems, potentially including GMP Quality Systems such as TrackWise, LIMS.
• Identify and address deviations from accepted practices.
• Apply Data Integrity principles in compliance with company guidelines.
• Act as a back-up to the supervisor and make independent quality decisions with input.

Skills:

• Perform tests for In-Process, Lot Release, and Stability studies.
• Support Utility and HVAC monitoring and sampling throughout the facility.
• Review assay results and ensure they meet required standards.
• Train team members and provide technical guidance.
• Write Quality Records including Deviations, CAPA, Change Control, and Test Methods.
• Manage projects, including method transfers, new instruments, and method qualifications.
• Utilize Microsoft Suites (Word, Excel, PowerPoint) for documentation and reporting.
• Work with Laboratory computer systems, potentially including GMP Quality Systems such as TrackWise, LIMS.
• Identify and address deviations from accepted practices.
• Apply Data Integrity principles in compliance with company guidelines.
• Act as a back-up to the supervisor and make independent quality decisions with input.

Education/Experience:

• Education: Bachelor's Degree in Microbiology, Biochemistry, or related science fields.
• Experience: 5-10 years of relevant experience in a microbial control or quality control setting, ideally within a GMP environment.