11 month contract with view to extension.

Shift role – 7am to 7pm – 4 days on and 4 days off

Purpose

The QC Microbiology Analyst role is a critically important activity to ensure efficient and effective compliant, qualification, and operation of the new strategic Drug Substance facility. This tremendous opportunity will be responsible for qualifying the Microbiology Quality Control lab and the verification of Microbiological analytical methods including but not limited to cutting edge Rapid Microbiological Methods. This person will be key in the layout of the lab testing flow to ensure the process is streamlined and in line with lean principles.

Responsibilities

Perform and carry out a variety of routine microbiological analytical techniques including but not limited to environmental monitoring, WFI sampling & testing, growth promotion testing, TOC & Conductivity testing, in-process product testing, final product testing such as bioburden and both Kinetic turbidimetric and MCS rapid endotoxin testing in compliance with GMP requirements.
The motivation to be an inspiring member of a high performing team.
The desire to continuously learn, improve and develop.
Perform supportive activities for general lab readiness, laboratory equipment qualification and method qualifications.
To integrate and complete all documentation on time and be familiar with LIMS.
Follow up-to-date analytical practices with reference to pharmacopoeias, specifications, regulations, and industry standards.
Support the laboratory testing schedule to achieve an efficient QC system.
Receive and manage samples that come into the lab for testing.
Solution preparation, cleaning, routine equipment maintenance and system set-up.
Writing and update of SOPs.
Maintain good housekeeping and GLP within the laboratory.
Calibrate and maintain all designated laboratory instruments.
Participate in risk assessments, inspections, audits, incident investigations, etc. and implement and follow-up on corrective / preventative measures.
Ensure training is current for all job functions performed.
Assist in training new analysts on routine procedures and practices.
Order stock and receive laboratory supplies.
Maintain data integrity and ensure compliance with company SOPs, specifications, and cGMP regulations.
Ensure that cGMP standards are maintained at all times.
Delivery of area performance to meet or exceed performance or quality goals.
Promote and participate in the implementation and maintenance of the relevant safety programmes.
Participate and comply with the company Quality Management System requirements.
Responsible for driving a culture of Continuous Improvement.

Requirements

1-3 years industry experience with significant knowledge and experience working in a Microbiology Laboratory.
Experienced in testing as per the pharmacopeia’s.
Working knowledge of QC Systems (eLogs, Electronic Lab Notebook, LIMS etc.).
Bachelor’s Degree qualification (Science/Quality/Technical).
Masters preferred.
Preference Lean Six Sigma.