QC Microbiology Senior

Title: QC Microbiology Senior

Contract Length: 12 Months

Pay rate: €30 - €34/hour

Work Schedule: Monday to Friday, 37.5H/W

Location: Dun Laoghaire, Co.Dublin, Ireland

Role Overview:

Our client is looking for a QC Microbiology Senior to be responsible for one or more of the following activities in QC including microbiological testing, method transfers, sample and data management and equipment maintenance. The successful candidate will join the QC Microbiology Lab Product Team to carry out Endotoxin, sterility, Bioburden, Water utility monitoring and Support duties.

Some of the responsibilities for the QC Microbiology Senior may include:

• Endotoxin testing of water, in-process, and drug product release samples.
• Bioburden testing of water & in-process drug product samples.
• Sterility testing
• Water sampling
• Lab Support duties such as Biological Indicator testing, Growth Promotion, Media Preparation, Identifications and Autoclave.
• Write protocols and perform assay validation.
• Introduce new techniques to the lab, including method transfers, reports, validations, and protocols.
• May participate in lab investigations.

Basic Qualifications:

• Bachelor's degree in a science discipline
• 2+ year's Bio-pharmaceuticals QC experience in a microbiology lab
• Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products

Preferred Qualifications and Experience:

• Experience working in endotoxin, bioburden, or sterility testing.
• Proficient in GMP systems such as LIMS Labware & LMES
• Experience in a wide variety of microbiological techniques, including but not limited to Bioburden, Endotoxin, Sterility (in an Isolator), Rapid Micro techniques, Microbial Identification, Media prep, Water Sampling.
• Technically strong background in microbiology and aseptic manufacturing
• Experience in LIMS, Change Control, Trackwise, SAP and CDOCS an advantage.
• Understanding and application of principles, concepts, theories, and standards of GMP QC microbiology laboratories. Deepens technical knowledge through exposure and continuous learning.
• Knowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery Skills

Knowledge and Skills:

• Take initiative to identify and drive improvements.
• Excellent verbal and written communication skills
• Strong Technical writing skills for GMP documentation (e.g., investigations, procedures, change controls)
• Presentation skills
• Escalate issues professionally and on a timely basis.
• Decision Making skills.
• Teamwork and Coaching others
• Negotiation and Influence skills
• Problem solving skills.
• Applies research, information gathering, analytical, and interpretation skills to problems of diverse scope.
• Ensures compliance within regulatory environment.
• Develops solutions to technical problems of moderate complexity.
• Screens, categorises, evaluates, reconciles, reports, and resolves data integrity issues.
• Interprets generally defined practices and methods.

Competencies:

• Flexibility - the role often encounters changing priorities (also required to work weekend on call - Rota system)
• Demonstrated ability to work independently and deliver right first-time results.
• Works under minimal direction, Recognises and escalates problems.
• Work is guided by objectives of the department or assignment.
• Follows procedures.
• Refers to technical standards, principles, theories and precedents as needed.
• May set project time-frames and priorities based on project objectives and ongoing assignments.

Does this sound like you? If so, please apply today!

Get in touch to discuss this role!

My number is 020 7 551 0727

jkirlew@i-pharmconsulting.com