Quality Control Scientist (Microbiology)

Quality Control Scientist (Microbiology) focusing on microbiological test methods, including Endotoxin, Low Endotoxin Recovery, Bioburden, and Sterility. Provide critical microbiology support to cell-culture, manufacturing (drug substance and drug product), and facilities.

Responsibilities:
- Perform test method validations, studies, and troubleshooting support (Investigations).
- Maintain departmental compliance with regulatory guidelines; drive continuous improvements for microbiological methods.
- Participate in aseptic process simulation activities.
- Support Change Control activities (initiation, impact, and implementation), including workflow and CAPA initiation/closure.
- Write technical documents and studies to troubleshoot and support investigations.
- Create and update SOPs.
- Gather and evaluate microbiological data to support investigations and business decision-making.
- Evaluate microbiological data entry, analysis, and reporting; support implementation of changes to identify streamlining opportunities.
- Seek and evaluate alternative solutions/workarounds; obtain organizational buy-in and solve problems effectively.

Qualifications/Required:
- BS/BA in microbiology (or closely related field).
- 2+ years working experience in a microbiology lab (preferably biotech).

Preferred:
- Advanced degree.

Skills/Tools:
- Knowledge of microbiological test methods for drug substance, drug product, gene therapy, raw materials, utilities, and disinfectants.
- Strong written, verbal, and interpersonal communication skills.
- Ability to handle multiple priorities with strong organizational and time management.
- Experience with BMRAM, Discoverant, documentation compliance, LIMS, Microsoft Word, Microsoft Excel, and process compliance.

Application Instructions:
- Apply now.