Quality Control Microbiologist

Role Summary:

• Our client based in Co. Waterford is looking for a QC Microbiologist to join their busy biopharmaceutical facility.
• The function of this position is to provide chemistry support and knowledge to the QC team and to other departments.
• This position also includes performing QC testing by following approved methodology to assure that the safety, quality, purity and stability of the products, components and in-process stages are in compliance with approved specifications.
• The chemistry team is highly flexible and provides cross functional support.
• This role allows opportunity to become highly skilled within the team and gain experience in all areas essential to the running of a microbiology department.

Core Duties and Responsibilities:

• Provide Microbiology support to the Quality Assurance, Qualified Persons, Validation and Manufacturing departments as well as other areas on site.
• Documentation review and batch release review.
• Provide technical guidance and expertise to QC Microbiology Team and external departments. In particular, close contact maintained with Validation, Manufacturing, Planning and Quality Assurance.
• Execution of QC Microbiology testing (water sampling, water testing, environmental monitoring, compressed air/nitrogen and more) as required.
• Compliance with cGMP and Standard Operating Procedures and pharmacopeias at all times.
• Actively contribute to continuous improvement initiatives in the lab.
• QC Microbiology representation at cross functional meetings.
• Providing audit support for tours and presentations as required.
• Supporting projects as required.

Minimum Qualifications and Experience:

• Bachelors Degree in a Scientific discipline (Biology, Chemistry, Biotechnology, Biochemistry or Food science preferred)
• 2-3 years working within a QC department in a Pharmaceutical or GMP facility would be an advantage
• Experience in Microbiological techniques is an advantage.
• Excellent communication skills, natural influencer, and ability to work effectively in cross -functional teams as well as working solo
• Understands Key Performance Indicators
• Knowledge of quality management systems (e.g. Veeva/Qualipso/Trackwise)
• Knowledge of lab management systems (e.g. LUNA)