QC Microbiology Analyst

Job Description

A fantastic and exciting opportunity has arisen for aQC Microbiology Analyst our Commercial Large-Scale Drug Substance Biotech facility in Swords.

This role is a critically important activity ensuring efficient and effective compliant design construction qualification and operation of the Biotech Drug Substance facility in Swords. This position will be responsible for qualifying the Microbiology Quality Control lab and the transfer 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.

Bring energy knowledge innovation to carry out the following:

• Perform supporting activities for general lab readiness laboratory equipment qualification and method transfers.
• Perform and carry out a variety of routine microbiological analytical techniques environmental monitoring WFI testing growth promotion testing In-process product testing Final product testing such as bioburden and both Kinetic turbidmetric and MCS rapid endotoxin testing in compliance with GMP requirements.
• 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 stability in-process and release testing.
• Reagent preparation cleaning and routine equipment good housekeeping and GLP within the and maintain all designated laboratory instruments.
• Participate in risk assessments inspections audits incident investigations and implement and follow-up on corrective / preventative measures.
• Maintain data integrity and ensure compliance with company SOPs specifications and cGMP that cGMP standards are maintained at all times.
• Promote and participate in the implementation and maintenance of the relevant safety programmes.
• Participate and Comply with the Quality Management System requirements.
  

What skills you will need:

In order to excel in this role you will more than likely have:

• Degree qualification(Science/Quality/Technical).

• Minimum 3 yrs in a highly regulated drug substance manufacturing environment.
• Experience with routine microbiological analytical techniques and testing.
• Proficient in the use of GLIMS
• Strong problem-solving skills and attention to detail.

We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the worlds most challenging healthcare needs.

As an equal opportunity employer we are proud to be a company that embraces the value of bringing diverse talented and committed people together.

Please dont hesitate to contact the Talent Acquisition Advisor assigned to this role should you need any support during our recruitment process.

We are committed to flexible working where possible and this is why our Company has introduced a new hybrid working model for office-based colleagues around the world.

Please feel free to speak to us about what flexibility means to you during your application.

So if you are ready to:

Invent solutions to meet unmet healthcare needs please apply today.

Required Skills:

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

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Merck & Co. Inc. Rahway NJ USA also known as Merck Sharp & Dohme LLC Rahway NJ USA does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place introductions are position specific. Please no phone calls or emails.

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Relocation:

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