QC Lead, Microbiology

Job Description

An amazing opportunity has arisen for a QC Lead, Microbiology our state-of-the-art single use biologics facility in Dunboyne, County Meath, Ireland. This people lead role will be involved in managing key laboratory start-up and sustain activities, New Product Introduction, Micro Analytical Technology Transfer and Quality Control (QC) testing at our Dunboyne facility. The overall responsibility of this role is to support the Quality Control testing function.

Key responsibilities will include: 

• As the Microbiology Laboratory Lead, your role will be central to coordinating and overseeing the activities of our dynamic laboratory team.
• Assist Microbiology team supporting the technical transfer of products through to operation readiness: Method Transfer/Validation, Contamination control strategy, Aseptic training, Environmental Monitoring program, raw materials testing, product testing, in-processing testing, process validation and facility validation.
• Ability to translate the vision and goals of the company and site to the Quality team.
• Lead the Quality Control Micro team function through excellent influencing/collaboration skills and teamwork mindset.
• Bring excellent trouble shooting and problem-solving skills as well as an ability to coach and mentor teams through complex problems.
• Ability to challenge the status quo with a continuous improvement mindset.
• Apply a wide variety of lean tools and building lean capability within teams.
• Be a change agent who will support the organization with good change management tools and techniques.
• Promote talent development with a focus on creating a continuous learning organization through active coaching.
• For quality and compliance, collaborates with the QRM but accountable for creating a ‘right first time’ culture in the Quality Control group to support quality excellence.
• For safety, the individual is accountable to drive a culture of ‘everyone owns safety’.
• Top of Form

Your profile:

• A degree qualification in Science/Quality/Technical disciplines.
• Experience in the biotechnology and/or pharmaceutical industry and proven record of accomplishments.
• Leadership skills and experience managing a team and laboratory area.
• Excellent written and oral communication skills and presentational skills. Ability to effectively provide updates to key stakeholders and senior management locally and globally.
• In depth understanding of cGMP requirements for manufacturing and/or systems and compliance.
• In depth understanding of GMP, ICH, USP and global compendia regulations and guidance, particularly analytical method development and validation.
• Ability to think logically and be proactive under pressure.
• Flexible and self-motivated.
• Ability to challenge the status quo with a continuous improvement mindset.
• Ability to manage multiple priorities and know when to escalate issues for resolution.
• Demonstrated knowledge of Quality Management System tools, continuous improvement methodologies & in-depth understanding of site level products & related processes.
• Excellent communication skills (written and oral) to effectively communicate within all levels of the organization around concepts of design controls, design verification and validation activities; production & process controls; Corrective & Preventive Action (CAPA), complaints & risk management; & product quality improvement using tools such as six sigma, etc.

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. We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment.

So, if you are ready to:

Invent solutions to meet unmet healthcare needs, Impact the future by driving one of the world’s leading healthcare companies, and inspire your team to reach their full potential and push the boundaries of science and technology, please apply today.

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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