QC Microbiologist

Location
Dublin, Dublin West
Salary
EUR40000 - EUR45000 per annum + health insurance + 25 days holidays
Posted
20 Aug 2019
Closes
27 Aug 2019
Ref
QC Microbiologist
Contact
Ann Marie Corcoran
Sector
Scientific
Job Type
Permanent
Hours
Full-time
QC Microbiologist is required for a new purification and aseptic manufacturing plant for the Blood Protein Albumin in Dublin 22

This role offers a chance to work in a state of the art facility, in an innovative Biotechnology company with excellent career development opportunities and a clear and committed patient focus.

KEY RESPONSIBILITIES



· Purified Water/Water for Injection water microbiological bioburden (TVC) and Endotoxin (LAL) testing.

· Analytical testing including pH, Conductivity, Total Organic Carbon (TOC) and chemistry testing as required.

· Carry out environmental monitoring including Viable/non-viable particles monitoring in manufacturing facilities as required.

· Carry out in-process and finished product microbiology analysis including Total Viable Count (TVC), microbial ID, sterility and Endotoxin testing as required.

· Ensure laboratory processes, equipment and services are maintained in an operational (and safe) state.

· Participate in the technical transfer / validation of microbiological and analytical testing procedures.

· Ensure that all cGMP, company specifications, procedures and guidelines are followed.

· Investigate Out of Specification (OOS) and Out of Trend (OOT) results as required.

· Investigate Non-Conformances and actively lead subsequent corrective actions as required.

· Participate in and responsible for QC related CAPA's.



· Adhere to QC documentation system and prepare and review document change requests as required.

· Develop, improve and implement QC procedures, processes and systems.

· Support projects and continuous improvement initiatives within the Quality department and other functional areas.

· Participate in international project teams relating to QC and wider quality activities and travel maybe required.

· Adhere to safety standards to ensure a safe working environment while ensuring the laboratory is kept clean, tidy and safe at all times.

· Prepare for and support regulatory and internal inspections/audits.

· Provide hands-on guidance and training when needed.

· Ensures area of responsibility is maintained in a state of compliance and audit readiness.

· Maintain current knowledge of regulatory and industry standards, trends and advancements through independent reading and training.

· Flexibility and willingness to carry out shift work when required.



QUALIFICATIONS: Bachelor's degree in Microbiology, Biochemistry or closely related scientific field

EXPERIENCE: minimum of 2 years of related experience.



For a Full Job Description Contact Ann Marie Corcoran

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