Lead Quality Control Specialist

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 why's 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.
  
  

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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 year’s 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 why's 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.
  
  

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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 product. Since 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 don't hesitate to contact the Talent Acquisition Advisor assigned to this role should you need any support during our recruitment process.

Required Skills

Analytical Instrumentation, Analytical Instrumentation, Analytical Method Transfer, Animal Husbandry, Biological Analysis, Chemical Analysis, Clinical Data Interpretation, Continuous Process Improvement, Enzyme Linked Immunosorbent Assay (ELISA), Global Compliance, GMP Compliance, Integrity Management, Internal Auditing, Inventory Management, Ishikawa Diagrams, Laboratory Safety, Microbiological Analysis, Personal Initiative, Qualitative Testing, Quality Control Management, Quality Improvement Programs, Quality Management, Quality Process Development, Quantitative Assay, Sample Testing {+ 2 more}

Preferred Skills

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

VISA Sponsorship

Travel Requirements

Flexible Work Arrangements

Not Applicable

Shift

Valid Driving License

Hazardous Material(s)

Job Posting End Date

04/28/2026

• 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 R393543