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, will assist with the end-to-end contamination control and sterility assurance practices for cell therapy onsite aseptic manufacturing processes, contributions to assay and equipment validations, data analysis and data report and lab maintenance. The Analyst will participate in the training programs as well as support the Excellos Labs safety, GxP and Quality plans. In addition, the Analyst will have the opportunity to assist with continuous improvement of systems to support a growing company.

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.
• Assist with critical material qualification (e.g. growth promotion test), method transfer, method system suitability test, and method validation and verification.
• Analysis, trend, review and approval of QC data and documentations including contract lab testing records. Assist with generation of 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.
• Monitor and 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.
• Supports generation and revision of documentation, such as SOPs/Protocols, forms, change controls and technical reports.

Working Environment

• Work primarily in laboratory setting.
• Normal laboratory environment with biohazard precautions.
• May be exposed to blood or bodily fluids that may be capable of transmitting diseases.
• May be exposed to chemicals that may be hazardous.
• May be called on to work or attend meetings at other than routinely scheduled hours.

Physical Requirements

• Must be able to work on a computer up to 4-8 hours per day.
• Must be able to operate laboratory equipment.
• Must be able to accommodate repetitive motion such as pipetting.
• Must be able to stand for prolonged periods of time.
• Must be able to communicate clearly.
• May be required to lift up to 40 pounds.
• Must be able to gown into a ISO7 cleanroom.

Equipment Used

• General Laboratory equipment (examples include but are not limited to): air sampler, particle counter, sterility testing platform (Celsis Accel System, and Bac-T/Alert system), incubator, water bath, centrifuge, refrigerator/freezer (includes Liquid nitrogen freezer), sterile hood, cell counter, cell isolation and analysis system, FACs analyzer, Quantstudio 5, Endosafe PTS, Biofire.
• Laboratory Information Management Systems or similar software.

Qualifications

Education:

• 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.
• Familiar with quality tools such as 6M, 5why, FMEA, HACCP are preferred.
• Strong attention to detail and ability to follow written procedures.
• Previous experience with sterile technique and human biospecimens.
• Prefer experience in identification of microorganism.

• 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.

Salary range: $32 per hour - $38 per hour