Quality Control Analyst II or III - Microbiology

About the role

The Quality Control Analyst II or III – Microbiology will be an integral part of the quality control at Excellos Labs and perform QC testing according to established EM program and procedures, contribute to contamination control and sterility assurance practices for cell therapy onsite aseptic manufacturing processes, assist with assay and equipment validations, data analysis and data reporting, lab maintenance, and support continuous improvement initiatives.

Responsibilities

• Execute routine and non-routine environmental monitoring including viable air sampling, surface sampling, non-viable air sampling, and personnel monitoring in ISO classified grades 5, 7, and 8 clean room cGMP environments for cell therapy manufacturing.
• Perform microbiological assays such as sterility, endotoxin, mycoplasma, gram stain, and analytical assays such as cell count, Flow Cytometry, qPCR/ddPCR, ELISA as needed.
• Adhere to production schedules and collaborate with area managers to ensure on-time production logistics and fulfillment of client requests.
• Routinely gown and maintain certifications for all classified/controlled manufacturing areas.
• Aid with critical material qualification (e.g. growth promotion test), method transfer, method system suitability test, and method validation and verification.
• Analyze, trend, review and approve QC data and documents including contract lab testing records. Assist with generating Certificates of Analysis as needed.
• Identify EM excursions, deviations and abnormal assay results. Perform troubleshooting, investigation, and root cause analysis with defined CAPA actions in a GxP environment.
• Perform routine equipment and laboratory cleaning as scheduled.
• Perform sample and material handling such as receiving/submission/labeling/sampling/ checking/counting/storage.
• Maintain lab equipment and inventory (Chemicals, reagents/aliquots, and supplies) and partner with management to ensure QC safety and audit readiness.
• Comply with current Good Documentation Practices and data integrity policy throughout comprehensive QC processes and documentations for EM sampling, compendial or non-compendial testing, equipment operation, and lab notebook.
• Support the generation and revision of documentation, such as SOPs/Protocols, forms, change controls and technical reports.
• Work primarily in a laboratory setting.
• May be exposed to biohazard precautions, chemicals, and repetitive motion.
• Must be able to gown into a ISO7 cleanroom.
• May be required to lift up to 40 pounds.

Requirements

• Bachelor’s degree in microbiology, Biology or life science related field.
• 3+ years QC experience in environmental monitoring, microbiological testing in a cGMP manufacturing facility.
• Knowledge of relevant guidance such as 21CFR Part 210/211/820/1271, ISO 14644, USPs (61,63,71,85,1116), Ph. Eur 2.6.27 and 2.6.1, ICH Q2 and current Good Manufacturing Practices (cGMP) related to Quality Control operations and testing.
• Familiarity with quality tools such as 6M, 5why, FMEA, HACCP is preferred.
• Strong attention to detail and ability to follow written procedures.
• Previous experience with sterile technique and human biospecimens.
• Prefer experience in identification of microorganisms.

Qualifications

• Must be keenly detail-oriented, well-organized, self-motivated, flexible, and capable of independent work with changing priorities, and display good time management skills.
• Ability to adapt to new technologies.
• Interpersonal skills to establish and maintain professional relationships.
• Ability to work collaboratively as a member of a team and to communicate effectively within an interdisciplinary environment.
• Ability to work well under pressure with minimal supervision and meet critical timelines.
• Ability to work, learn, adapt, and execute in a fast-paced commercial environment.

Skills

• Must be detail-oriented, well-organized, self-motivated, flexible, and capable of independent work with changing priorities, and display good time management skills.
• Ability to adapt to new technologies.
• Interpersonal skills to establish and maintain professional relationships.
• Ability to work collaboratively as a member of a team and to communicate effectively within an interdisciplinary environment.
• Ability to work well under pressure with minimal supervision and meet critical timelines.
• Ability to work, learn, adapt, and execute in a fast-paced commercial environment.

Benefits

Flexible schedule, professional development opportunities, competitive salary range ($32 per hour - $38 per hour).

Pay

$32 per hour - $38 per hour

Schedule

Monday - Friday 8am - 5:30pm