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Quality Control Microbiology Associate Specialist

3 months ago

Swords Ontario, CA MSD Full time

A fantastic opportunity has arisen for a QC Microbiology Associate Specialist. This role is a critically important activity to ensure efficient and effective compliant operation of the new strategic Drug Substance facility. This person will be key in the day to day planning and running of lab testing to ensure the process is streamlined and in line with lean methodologies.

You will be the key leading talent in analytical techniques and developing the flow of testing through the lab, to ensure the lab will be best in class across our industry, a benchmark for others to aspire to. You will support the specialist role function in the lab and will provide support to other analysts within the lab area, including training and guidance on their area of expertise.

The full analytical scope will incorporate micro, chemistry, bioassay, raw materials, stability and in-process. Innovation and advanced analytical methods (rapid ID tech, paperless lab, etc) will allow the candidate challenge current thinking in designing for the future.

Bring energy, knowledge, innovation to carry out the following:
  1. Work as directed by the Associate Director Quality Control /Quality Control Manager (Bioanalytical) according to Company safety policies, cGMP and cGLP.
  2. Drive compliance with Global policies, procedures and guidelines and regulatory requirements and execute Good Manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions.
  3. Participate in the method transfer of analytical techniques for Chemistry testing.
  4. Plan and perform multiple, complex routine/ non-routine methods and procedure when required.
  5. Participate in the peer review of analytical data.
  6. Provide technical guidance and apply expertise and critical thinking to help to resolve technical issues.
  7. Lead training of staff on technical aspects of the role.
  8. Revise and implement procedures that comply with appropriate regulatory requirements.
  9. Qualification of analytical equipment and related testing functions.
  10. Compliance with Standard Operating Procedures and Registered specifications.
  11. Maintain quality systems within the QC laboratories to ensure ongoing compliance to cGLP and cGMP.
  12. Participate in laboratory Investigation Reports and deviations through the Non-Conformance procedures.
  13. Participate in the generation and update of SOP’s, trend data, investigations, nonconformances, validation protocols, reports, method validation/verifications and equipment qualifications.
  14. Plan and implement procedures and systems to maximise operating efficiency.
  15. Contribute to the achievements of department productivity and quality goals.
  16. Represent the QC Department on site/inter departmental projects.
  17. Provide support with audit/inspection requirements to ensure department compliance/readiness.
  18. Plan and maintain the laboratory testing schedule to achieve an efficient QC system.
  19. Maintain good housekeeping and hygiene within the laboratory.
  20. Participate in risk assessments, inspections, audits, incident investigations, etc. and implement and follow-up on corrective / preventative measures.
  21. Ensure training is current for all job functions performed.
  22. Participate in internal and external audits and inspections, taking the role of auditee for assigned areas of responsibility.
  23. Drive continuous improvement, perform root cause analysis on system failures and substandard equipment performance, using standard tools and methods, to resolve machine and system issues.
What Skills You Will Need

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

  1. Relevant experience and skill sets in their area of expertise that adds value to the business; ideally in a manufacturing, preferably in a GMP setting.
  2. Experience and critical skills in the area of expertise that add value to the business; ideally analytical microbiology, in a GMP setting.
  3. Knowledge of regulatory/ code requirements to Irish, European and International Codes, Standards and Practices.
  4. Knowledge of cGMP.
  5. Laboratory Quality Systems.
  6. Report, standards, policy writing skills required.
  7. Lean Six Sigma Methodology experience.
  8. Understand the specific responsibilities of all departments as they relate to ones own department, understanding the business processes ones department supports.
  9. Effective communication, presentation and interpersonal skills, to interface effectively with all levels of colleagues and with external customers in a team orientated manner.

As a company, we are committed to 'Inventing for Life' in all that we do. We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world's 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 don't 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 or click on the link to find out more about our hybrid working model.

So, if you are ready to Invent solutions to meet unmet healthcare needs, please apply today.

Current Employees apply HERE
Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully

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.

Employee Status Regular
Relocation No relocation
VISA Sponsorship Not applicable
Travel Requirements Not applicable
Flexible Work Arrangements Not Applicable
Shift Not applicable

Job Posting End Date 08/23/2024

A job posting is effective until 11 59 59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID R299396

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