QC Specialist Separations

Johnson & Johnson MedTech; Ringaskiddy; On-site; EUR 52,000 - 83,000; Full time

Job summary

Johnson & Johnson MedTech in Ringaskiddy, Cork, Ireland is seeking a QC Specialist – Separations to join our Quality Control team. You will provide technical expertise for analytical testing, equipment qualification, method transfer activities, investigations, and continuous improvement in a regulated pharmaceutical environment.

The role requires knowledge in Chemistry, Biochemistry, or Microbiology, and prior supervisory experience in an IMB/FDA-regulated setting.

Qualifications

• Minimum of 3 years of experience within the pharmaceutical industry.
• Prior supervisory experience in an IMB/FDA-regulated facility.
• Knowledge of FDA and EMA regulatory requirements applicable to biologics and/or pharmaceuticals.

Responsibilities

• Supporting day-to-day testing operations.
• Coordinating qualification of analytical equipment and testing functions (HPLC, Spectrophotometry, Nephelometry, TOC).
• Coordinating sampling and testing during plant and laboratory utility qualification.
• Planning analytical method transfer activities for NMEs.
• Coordinating testing and sampling for raw materials, utilities, in-process samples, final bulk and finished products.
• Supporting analyst training programs.
• Reviewing and approving laboratory data and QC investigations.
• Reviewing specifications and LIMS scheduling activities.
• Reviewing and approving deviations, CAPAs, and Change Controls.
• Planning and overseeing laboratory projects, including method transfers and equipment qualification.
• Identifying and supporting laboratory process improvements.
• Training personnel on analytical technologies.
• Presenting analytical information to stakeholders and inspectors.
• Maintaining awareness of analytical technology developments and compliance trends.

Skills

Collaboration and teamwork

Critical thinking

Problem-solving

Attention to detail

Results-oriented

Coaching and mentoring

Integrity, objectivity, accountability

Clear communication

Adaptability

Innovative mindset

Inclusive and collaborative working

Analytical reasoning

Business behavior

Compliance management

Controls compliance

Quality auditing

Quality control

Quality systems documentation

Report writing

Technologically savvy

Job description

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.Learn more at jnj.com.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function

Quality

Job Sub Function

Quality Control

Job Category

Professional

All Job Posting Locations:

Ringaskiddy, Cork, Ireland

Job Description

We are searching for the best talent for a QC Specialist – Separations.

Purpose

We are looking for a QC Specialist – Separations to join our Quality Control team.

In this role, you will provide technical expertise and support for Quality Control laboratory activities within a regulated pharmaceutical manufacturing environment. You will work closely with laboratory teams and cross-functional partners to support analytical testing, equipment qualification, method transfer activities, investigations, and continuous improvement initiatives.

The role requires sound technical knowledge of analytical techniques and laboratory equipment in one or more of the following areas: Chemistry, Biochemistry, or Microbiology. Previous supervisory experience in an IMB/FDA-regulated environment is required.

You will be responsible for

Working closely with the QC Manager and laboratory teams, you will provide technical support for testing operations and contribute to the delivery of compliant and efficient Quality Control activities.

Key Responsibilities Include

• Supporting day-to-day testing operations
• Coordinating qualification of analytical equipment and associated testing functions, including technologies such as HPLC, Spectrophotometry, Nephelometry, and Total Organic Carbon systems
• Coordinating sampling and testing activities during plant and laboratory utility qualification
• Planning and coordinating analytical method transfer activities for relevant New Molecular Entities (NMEs)
• Coordinating analytical testing and sampling activities for raw materials, utilities, in-process samples, final bulk, and finished products
• Supporting implementation of analyst training programs
• Reviewing and approving laboratory data and Quality Control investigations
• Reviewing specifications and supporting associated LIMS scheduling activities
• Reviewing and approving deviations, CAPAs, and Change Controls
• Planning and overseeing laboratory projects, including method transfers and equipment qualification activities
• Identifying and supporting laboratory process improvements
• Training laboratory personnel on specific analytical technologies
• Providing technical support on analytical technologies
• Supporting lean initiatives related to laboratory operations, including test execution, documentation updates, and equipment qualification activities
• Presenting analytical and technical information clearly and concisely to internal stakeholders and regulatory inspectors
• Maintaining awareness of analytical technology developments and compliance trends

The role partners with other departments and Team Leaders to help ensure Quality Control activities are completed effectively and in accordance with GMP requirements.

Qualifications / Requirements

• Minimum of 3 years of experience within the pharmaceutical industry
• Prior supervisory experience working in an IMB/FDA-regulated facility
• Knowledge of FDA and EMA regulatory requirements applicable to biologics and/or pharmaceuticals

Technical Knowledge

• Sound technical knowledge of analytical techniques and laboratory equipment in Chemistry, Biochemistry, and/or Microbiology
• Experience supporting analytical testing, equipment qualification, and analytical method transfer activities

Skills

• Collaboration and teamwork
• Critical thinking
• Problem-solving and attention to detail
• Results-oriented approach
• Coaching and mentoring capabilities
• Integrity, objectivity, and accountability
• Customer focus
• Clear communication skills
• Adaptability and flexibility
• Innovative mindset
• Inclusive and collaborative working style

Individual Contributor Competencies

• Builds strong and productive relationships
• Works effectively with teams and individuals
• Uses persuasion and influence to support decision-making
• Seeks opportunities for professional growth and development
• Uses best practices to improve business operations
• Maintains accountability for compliant execution
• Takes responsibility for decisions and outcomes
• Manages and adapts to change effectively
• Remains open to different perspectives and ideas
• Works effectively with people who bring diverse experiences and viewpoints
• Maintains high ethical standards
• Demonstrates an understanding of AI concepts and frameworks, including awareness of responsible and ethical AI practices, and uses effective prompting techniques to support efficiency and productivity

What we offer

We offer a collaborative and inclusive environment where learning, innovation, and professional development are encouraged.

In this role, you will have opportunities to work with advanced analytical technologies, contribute to critical quality activities, and support products that make a meaningful difference for patients.

Additional role information

All employees are expected to comply with Environmental, Health & Safety requirements, site procedures, and applicable regulations.

This role may require interaction with regulatory inspectors and participation in audit and inspection activities as part of normal responsibilities.

Our commitment to inclusion

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation is powered by bringing together people with different backgrounds, experiences, and perspectives.

We are proud to be an equal opportunity employer and welcome applications from qualified candidates of all backgrounds.

If you require a reasonable accommodation during the application, interview, or onboarding process, support is available. Please let us know how we can help.

Preferred Skills:

Analytical Reasoning, Business Behavior, Compliance Management, Controls Compliance, Cross-Functional Collaboration, Innovation, ISO 9001, Persistence and Tenacity, Problem Solving, Process Oriented, Quality Auditing, Quality Control (QC), Quality Control Testing, Quality Standards, Quality Systems Documentation, Report Writing, Technologically Savvy

The Anticipated Base Pay Range For This Position Is

€52 400,00 - €82 915,00

Benefits

In addition to base pay, we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions. Moreover, we offer vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement, programs for financial, physical and mental health. We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans. For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers.

• This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.