Quality Control Lead Technician

Job Description

We have an immediate vacancy for Quality Control Lead Technician to performs and review 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. Your will provide technical expertise, trouble-shooting, training and support to laboratory technicians and ensure that objectives are effectively achieved, consistent with company’s requirements to ensure compliance, safety and reliable supply to our customers.

Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.

Principal Accountabilities

• Work as directed by Quality Coach according to Company safety policies, cGMP and cGLP.
• Drive compliance with 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.
• Leader activities including selection, development, coaching and day to day management.
• Ensure that the team receives appropriate resources and programmes to develop technical and other skills, to complete their jobs whilst stimulating personal growth and development in line with role.
• Develop and maintain training programmes.
• Comply with 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.
• Operate as part of self-directed team in allocating testing and assigning priorities. Oversee testing ensuring a high degree of precision and accuracy is maintained.
• Act as Area owner for the QC components inspection and analytical laboratories. Formulating weekly work schedules with the Quality Manager and ensuring that these schedules are
• communicated and followed.
• Facilitate and drive effective communication to ensure success. Facilitate the QC Tier 1 daily meeting and ensuring that QC representatives attend all required department Tiers.
• Where applicable, review, approve and trend incoming materials and finished product testing.
• Review analyst documentation and ensuring QC Right First Time KPIs are achieved.
• Ensure that all Quality Systems within the department are adhered to on a daily basis.
• Train QC team members and regular review of training records, to ensure compliance.
• Involvement in QC equipment projects including purchasing and ensuing validation. Work on projects as detailed by Quality Manager.
• Represent the QC Department on site/inter departmental projects.
• Provide lead analytical support to product quality investigations and new product demonstrations using own initiative and with minimum supervision. Provide leadership in the laboratory aspects of OOS investigations and provides sign-off as area owner on QC deviations.
• Provide support with audit/inspection requirements to ensure department compliance/readiness.
• Participate in internal and external audits and inspections, taking the role of auditee for assigned areas of responsibility.
• 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 e.g. FMEA, Fishbone diagrams, 5 why's etc, all under aseptic/clean room conditions.
• Provide input, review and approval for atypical, observation, and process capability investigations.
• Oversee coordination of resources to implement suggestions/ideas of merit. On assignment, and depending on experience, participate in or lead departmental initiatives on improved compliance and quality systems.
• Drive and participate effectively in writing/revising/ rolling out accurate operational procedures, training materials and maintenance procedures for various Quality systems; ensure all work is carried out in line with same. Understand and internalise procedures relevant to GMP operations.

May be required to perform other duties as assigned.

Skills and Knowledge

Typical Minimum Education: Bachelors Degree or higher preferred; ideally in a related Science, Engineering or other Technical discipline

Typical Minimum Experience: Relevant experience and a skill set in their area of expertise that adds value to the business; ideally in a manufacturing, preferably GMP setting.

Core Competences

• Technical: Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices, Knowledge of cGMP, Laboratory Quality Systems. Proficiency in Microsoft Office and job-related computer applications required. Report, standards, policy writing skills required. Understanding of Lean Six Sigma Methodology preferred
• Business: Excellent communication, presentation and interpersonal skills, to interface effectively with all levels of colleagues and with external customers in a team orientated manner. Understand the specific responsibilities of all Carlow departments as they relate to one’s own department, understanding the business processes ones department supports. Flexible approach, proven organizational skills, Planning and scheduling skills, Effective time management and multi-tasking skills, Excellent attention to detail and trouble shooting skills
• Leadership: Focus on Customers and Patients, Collaborate, Act with Candor and Courage, Make Rapid, Disciplined Decisions, Drive Results, Build Talent and Demonstrate Ethics and Integrity.

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. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively for the common good. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

THE COMPANY

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.

CARLOW

Our site in Carlow is a world-class manufacturing facility, and our company’s first stand-alone vaccine and biologics facility outside the USA. Carlow employs over 350 highly skilled employees and is an important element of our company’s’ network of sites, playing a pivotal role in the manufacture of our immuno-oncology treatment. The site is a state-of-the-art, 200,000 sq. ft vaccines and biologics facility focused on formulating and filling vaccine and biologic products that improve and transform the lives of people across the world. We are growing our highly-skilled team and building our presence in Carlow so that we can continue to lead scientific breakthroughs in the treatment of some of the world’s most challenging diseases.

What we look for …

In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.

INVENT.

IMPACT.

INSPIRE.

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, 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:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

Requisition ID:R34039