Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office

Job Description

At Thermo Fisher Scientific Inc., the QA Lead – Biologics Sterility Assurance role offers an outstanding opportunity to ensure robust compliance of aseptic operations and sterility assurance systems across biologics manufacturing. This position is pivotal in driving excellence and flawless performance in contamination control, validation, and continuous improvement, strictly adhering to regulatory and corporate quality standards!

Key Responsibilities

Sterility Assurance System:

• Lead and uphold the Sterility Assurance Program and Contamination Control Strategy (CCS) for facility, utilities, equipment, materials, personnel, and processes.
• Lead risk assessments for aseptic processes, single-use systems, and critical interventions.
• Establish, assess, and authorize sterility assurance benchmarks; track, report, and intensify performance.

Aseptic Operations Oversight:

• Coordinate QA for aseptic processing for drug substance and drug product (e.g., upstream bioreactors, downstream filtration, UF/DF, DS).
• Perform routine Gemba/walkthroughs and provide on-floor QA support during aseptic operations.

Environmental & Utilities Control:

• Oversees planning, execution, and monitoring of environmental monitoring programs.
• Investigate EM excursions and drive CAPA efficiency and preventive actions.

Sterilization & Decontamination:

• Provide QA oversight of sterilization methods, load configurations, biological indicators, and requalification schedules.
• Approve sterilization cycle development, validation protocols/reports, and change controls for single-use assemblies, filters, and aseptic connectors.
• Ensure validated cleaning and decontamination procedures for equipment and rooms (including sporicidal rotations).

Quality Systems & Compliance:

• Evaluate, assess, and endorse SOPs, validation protocols, master batch records, and QA standards linked to aseptic operations.
• Lead and respond to internal/external audits (e.g., FDA, EMA, MHRA, PIC/S); ensure readiness and remediation.
• Lead deviations, root cause analyses, CAPA, and efficiency checks for sterility-related issues (bioburden, endotoxin, EM).
• Lead QA for changes impacting sterility (facility, equipment, single-use components, filters, cleaning agents, disinfectants).
• Support tech transfers for new biomolecule products/processes ensuring sterility requirements are incorporated into process development and validation.

Training & Culture:

• Formulate and present aseptic behavior training, gowning certifications, and programs highlighting proficiency in sterility assurance.
• Mentor operations and QA staff to reinforce contamination control culture and right-first-time behaviors.

Qualifications:

• Bachelor’s or Master’s or equivalent experience in Microbiology, Biotechnology, Pharmacy, Chemical/Biomedical Engineering, or related field.
• 5+ years in GMP biologics or sterile manufacturing with 2+ years in QA sterility/aseptic leadership.
• Profound understanding of aseptic processing, EM, validation of sterilization, and control of contamination in biologics.
• Strong experience with investigations (root cause analysis), CAPA, risk management, and audit interactions.
• Excellent communication, collaborator management, and decision-making under time-sensitive operations.
• Proficiency in maintaining sterility standards and hands-on aseptic supervision.
• Detailed problem solving and risk-based thinking.
• Continuous improvement approach.