Website Ref: TPM04218
A QC Microbiology Analyst is required for a biopharmaceutical company in Cork. The successful candidate will be responsible for performing testing, review and report writing for Environmental Monitoring, Clean Utility Systems, Growth Promotion of media and other microbial testing onsite.
- The Sr. Analyst will be responsible for performing testing compliant with cGMP guidelines.
- Work assignments will encompass performing and documenting activities from routine to semi-routine in nature, and requires the ability to recognize deviations from the accepted practice.
- The Sr. Analyst will be responsible for the timely completion of assignments.
- Good record keeping, organizational, written, and verbal communication skills are essential.
- The Sr analyst must be willing to work overtime and weekends as required.
- Report writing including trend reports and other reports as required.
- Management of stock, ordering of reagents as required.
- Overview of samples sent to external testing labs and liaising with external labs.
- Timely review of test data against defined criteria/specifications, SOPs, GMP guidelines.
- Quality and compliance driven, identifies any issue and helps resolve, solution focused.
- Excellent written English to support report writing, deviations, LIRs, CAPAs and change controls, SOP updates.
- Ability to follow written instructions and to perform tasks with minimal supervision.
- Supports audits to ensure the laboratory areas are inspection-ready and provides SME skills.
- Interacts with other departments on a regular basis, deputise and represent the team when required.
- Develops and maintains proficiency in a broad range of trained test methods and is willing to upskill with other test methods.
- Trains other analysts in areas of expertise.
- Seeks, learns, and applies new job related training and knowledge and shares knowledge with co-workers.
- Holds self and others responsible to abide by department and company policies and practices.
- Leads by example demonstrating good behaviours in the laboratory environment.
- Familiarity with cGMP, 21CFR, USP, EP and ICH regulatory requirements.
- Flexibility to work in a dynamic environment.
- Familiarity with use of a computer: e.g., Proficient in Windows, Microsoft Word, Excel.
- Works independently as well in a team environment.
Qualifications & Experience:
- B.S./B.A. in Science (major in microbiology-biochemistry-biomedical science)
- A M.Sc. in a relevant degree is preferable.
- 3-5 years in a cGMP/GLP laboratory; quality control experience in Microbiology is preferred.
- Good understanding of In process testing requirements to support business.
- Strong knowledge and experience with microbiological testing including Environmental Monitoring, Clean Utilities, Growth Promotion of Media and Biological Indicator testing.
To apply for this job email your details to firstname.lastname@example.org.