Quality Control Analyst

About the Company

Lifecycle Biotechnologies, a TCP Analytical Company in the life science industry for 40 years is looking for a Quality Control Analyst, based out of Cleburne, Texas.

About the Role

The QC Laboratory Analyst has a critical role in ensuring the safety and sterility of advanced therapy medicinal products (ATMPs) within the regenerative medicine field. This position focuses on the execution of specialized microbiological assays, with a primary emphasis on sterility testing for cell-based therapies and tissue-engineered products.

Responsibilities

• Sterility Testing: Perform routine and non-routine sterility testing of raw materials, in-process samples, and final products using methods such as Membrane Filtration and Direct Inoculation.
• Rapid Microbial Detection: Execute alternative sterility methods (e.g., BacT/ALERT, BACTEC, or ATP-bioluminescence) specifically designed for the rapid release of short-shelf-life regenerative products.
• Perform Environmental Monitoring (EM) including viable and non-viable sampling within Grade A/B cleanroom environments to ensure aseptic processing conditions.
• Perform Ancillary Microbiological Testing including Endotoxin (LAL) testing, Bioburden analysis, Gram staining, and Mycoplasma detection.
• Benchtop and Wet Chemistry assays as applicable to manufacturing requirements.
• Quality Compliance: Adhere strictly to current Good Manufacturing Practices (cGMP), USP sterility standards, and Good Documentation Practices (GDP).
• Laboratory Investigations: Initiate and support investigations into Out-of-Specification (OOS) results, environmental excursions, and deviations.
• Cleanroom & Environmental Oversight: Monitor personnel for adherence to ISO 14644-5 aseptic techniques and gowning procedures.
• Verify cleanroom status and equipment cleanliness before and during production.
• Line Clearance: Execute formal line clearances between batches to ensure no materials, components, or documents from previous runs remain.
• Perform First Article inspections.

Qualifications

• Bachelor’s degree in Biology, Microbiology, Chemistry, or a related technical field is preferred. Applicable equivalent experience will be considered.
• 2–5 years of experience in a cGMP laboratory environment, preferably within the biotech or regenerative medicine industries.

Required Skills

• Proven proficiency in aseptic technique and working within controlled environments.
• Direct experience with USP and/or Rapid Sterility methods.
• Familiarity with growth promotion and suitability testing to validate sterility methods.
• Established skills in both microbiological and chemical assays.
• Experience with environmental monitoring or aseptic techniques in a regulated manufacturing environment (e.g., pharmaceutical, biopharmaceutical) is preferred.
• Strong understanding of cGMP regulations, FDA requirements (e.g., 21 CFR Parts 210 and 211, 820), ISO 13485, and aseptic techniques.
• Direct experience with regulatory inspections (e.g., FDA, EMA).
• Proficiency in electronic Quality Management Systems (eQMS) and labeling software.
• Excellent attention to detail and strong organizational skills.
• Proven ability to complete documentation accurately and maintain data integrity.
• Strong verbal and written communication skills.
• Ability to work independently and as part of a team.
• Proficiency with basic computer applications, including Microsoft Office.
• Familiarity with Six Sigma or Lean Manufacturing principles for process improvement.

Ability to work in a classified cleanroom environment, which requires adherence to strict gowning procedures and protocols for extended periods. Willingness to work flexible hours, which may include evening, weekend, or holiday shifts to align with production schedules. Ability to lift and move equipment or supplies as needed.

Equal Opportunity Statement

Lifecycle Biotechnologies is proud to be an equal opportunity employer.

We are an Equal Employment. We do not discriminate in hiring on the basis of sex, gender identity, sexual orientation, race, color, religious creed, national origin, physical or mental disability, protected Veteran status, or any other characteristic protected by federal, state/province, or local law.