Qc Microbiology

**About us**

Viralgen is a CDMO born as a joint venture between AskBio and Columbus Venture Partners created in response to the unmet need for manufacturing of gene therapies. Our goal is to help broaden the access to these life-saving therapeutics and contribute to the advancement of health and human welfare around the world.

We are excited for our next QC Microbiology to join the Viralgen team

**About the role**

Collaborate in the coordination of processes for Viralgen's microbiology quality control laboratories. Assess and identify regulatory and quality risks in microbiology activities and processes; collaborate with area manager in gap analysis, implementation of quality system policies and procedures. Lead multiple process/product improvement projects. Demonstrates effective decision making, problem solving, project management.

**Responsibilities**
- Collaborate in the implementation of the Contamination Control Strategy (CCS) according to Annex I.
- Collaborate with the person in charge of the Microbiology Department.
- Analyze the feasibility of techniques for the characterization of new batches.
- Collaborate in reviewing validation of characterization results for TOXO and GMP batches, collect historical data, support trend analysis and review and investigation of unexpected results.
- Participate in the validation of analytical methods.
- Collaborate in reviewing incidents and change controls reported by department supervisors, report them to QA and manage CAPAs.
- Write and report general issues and change controls affecting QC-Microbiology.
- Collaborate and actively participate in analytical method development.
- Review all modifications to standard operating procedures (SOPs).
- Write/review protocols and qualification/validation reports.
- Provide support in analyzing the compliance of techniques developed in QC
- Microbiology with pharmacopoeia, ICH and other applicable regulations.

**About you**
- University degree in health sciences (biology, pharmacy, biochemistry, biotechnology, chemical engineering or similar).
- Master's or postgraduate degree in health sciences is desirable.
- Experience in analytical techniques based on microbiology and team coordination (minimum 3 years in similar tasks).
- Experience in Quality Control techniques associated with sterile drug manufacturing.
- NCF/GMP knowledge of at least 3 years.
- High/medium level of English, fluent in written and spoken English.
- Organizational and planning skills.
- Analytical skills.
- Fluent in English (mandatory) and Spanish (valuable).
- Proactive and positive attitude to change and challenges.
- Demonstrated ability to work both independently and in a team environment.
- Demonstrated ability to work well under pressure and meet tight deadlines.
- Demonstrated passion for producing high-quality work.
- Proactive management and positive attitude to change and challenges.
- Communication skills and self-management.

**Other benefits**
- Indefinite contract.
- Opportunities for professional development.
- Flexible schedule.
- Accompaniment in the learning and development process.
- Good working and international environment.
- Company activities.
- Social benefits.