Lead Tech, Quality Control

Job Description

A fantastic opportunity has arisen for a Lead Tech Quality Control.

Join a supportive growing team in the analysis of Biologics and Vaccines in a state-of-the-art Quality Operations laboratory. Our site will manufacture and test biggest selling biologic and the biggest selling vaccine product and is a strategic manufacturing site.

This role will report directly to the QC Manager and will help us in the expansion of this Laboratory.

The lab operates a 2 cycle and 4 cycle shift and roles are available in both.

Occasional travel may be required for training purposes.

Bring energy knowledge innovation to carry out the following:

• Performs and reviews all routine and non-routine testing and project work to ensure processes and end products comply with corporate and regulatory requirements to facilitate product release.
• Participate in method transfers and provide technical expertise and provide analytical support. Act as a method SME while driving continuous improvements performing root cause analysis on system failures and substandard equipment performance using standard tools and methods to resolve machine and system issues e.g. FMEA Fishbone diagrams 5 whys etc
• Act as a lead in QC team performing the allocated testing and laboratory based duties and leading troubleshooting activities.
• Perform various analytical techniques including but not limited to HPLC (HIC CE IEX HP-SEC) Capillary Electrophoresis ELISA Cell Based Assays and other compendial test methods in compliance with GMP requirements. Mentor junior members of the team.
• Peer review and approve testing documentation and ensuring data integrity compliance and QC Right First Time KPIs are achieved.
• Lead laboratory aspects of OOS investigations.
• Drive the completion of all assigned data processing and reviewing across the lab team.
• Develop implement and maintain procedures that comply with appropriate
  regulatory requirements.
• Ensure that all Quality Systems within the department are adhered to on a daily
  basis.
• Ensure timely completion of Laboratory Investigation Reports and deviations
  through site procedures
• Lead QC Tier 1 daily meetings and ensure effective communication of
  testing progress deviations etc.
• Participate in the timely generation of trend data investigations nonconformances
  validation protocols reports in support of method validation/verifications and equipment qualification
• Take the lead in internal and external audits and inspections taking the role of auditee for assigned areas of responsibility answering audit comments where appropriate.
• Work as directed by the Quality Control Manager / Associate Director according
  to Company safety policies cGMP and cGLP. Required to drive compliance with
  Our Company 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.
• Comply with company Global Policies Procedures and Guidelines
  regulatory requirements and execute current Good Manufacturing Practices
  (cGMP)in the performance of day to day activities and all applicable job
  functions.

What skills you will need:

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

• Bachelors Degree or higher preferred; ideally in Analytical Chemistry/ Biochemistry or a closely related discipline
• The ideal candidate will have 2- 3 years experience in a pharmaceutical laboratory ideally with experience in HPLC and relevant systems and software. Core to the role is to perform testing of samples to support the release of our key drug products.

• A good working knowledge of HPLC systems and software is desirable
• A good knowledge of cGMP GLP Quality Management Systems

• Performs and reviews all routine and non-routine testing and project work to ensure processes and end products comply with corporate and regulatory requirements to facilitate product release.
• Participate in method transfers and provide technical expertise and provide analytical support. Act as a method SME while driving continuous improvements performing root cause analysis on system failures and substandard equipment performance using standard tools and methods to resolve machine and system issues e.g. FMEA Fishbone diagrams 5 whys etc
• Act as a lead in QC team performing the allocated testing and laboratory based duties and leading troubleshooting activities.
• Perform various analytical techniques including but not limited to HPLC (HIC CE IEX HP-SEC) Capillary Electrophoresis ELISA Cell Based Assays and other compendial test methods in compliance with GMP requirements. Mentor junior members of the team.
• Peer review and approve testing documentation and ensuring data integrity compliance and QC Right First Time KPIs are achieved.
• Lead laboratory aspects of OOS investigations.
• Drive the completion of all assigned data processing and reviewing across the lab team.
• Develop implement and maintain procedures that comply with appropriate
  regulatory requirements.
• Ensure that all Quality Systems within the department are adhered to on a daily
  basis.
• Ensure timely completion of Laboratory Investigation Reports and deviations
  through site procedures
• Lead QC Tier 1 daily meetings and ensure effective communication of
  testing progress deviations etc.
• Participate in the timely generation of trend data investigations nonconformances
  validation protocols reports in support of method validation/verifications and equipment qualification
• Take the lead in internal and external audits and inspections taking the role of auditee for assigned areas of responsibility answering audit comments where appropriate.
• Work as directed by the Quality Control Manager / Associate Director according
  to Company safety policies cGMP and cGLP. Required to drive compliance with
  Our Company 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.
• Comply with company Global Policies Procedures and Guidelines
  regulatory requirements and execute current Good Manufacturing Practices
  (cGMP)in the performance of day to day activities and all applicable job
  functions.

The Carlow site broke ground in 2008 and is a filling site for the launch and commercial supply of vaccines biologics and small molecule drug its initial launch the site has attracted significant internal investment and is now home to a number of state-of-the-art production facilities laboratories and temperature-controlled warehousing units. The Carlow site is a significant employer in the South East region and attracts high performing talent through close collaborations with universities and colleges in the region.

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.

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.

Employee Status:

Relocation:

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Travel Requirements:

Flexible Work Arrangements:

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