Quality Control Analyst (Microbiology)

Biopharma Careers; Little Island; On-site; EUR 42,000 - 68,000; Full time

Job summary

Johnson & Johnson, Cork, Ireland, is seeking a Quality Control professional to perform testing and ensure data integrity in a GMP environment. The role involves equipment calibration support, data logging, and cooperation with QA, Manufacturing and other functions to meet KPI targets.

The candidate should have Level 7 in a scientific/technical discipline, lab experience, and a strong understanding of FDA/EMEA regulations for biologics/pharmaceuticals.

Qualifications

• Level 7 in a scientific/technical discipline is required.
• Experience in the lab or similar QC role.
• Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals.
• Performance driven and a team player.
• Good communicator.

Responsibilities

• Perform assigned testing and laboratory activities accurately and safely.
• Support operation, calibration, maintenance and qualification of laboratory equipment.
• Document and report laboratory data in GMP-compliant records.
• Support material release, sample scheduling and KPI achievement.
• Collaborate with QA, Manufacturing and other functions to ensure QC activities.
• Support internal and external audits and regulatory inspections.

Skills

Team player

Good communicator

Analytical reasoning

Continuous improvement

Execution focus

Education

Level 7 in scientific/technical discipline

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:

Cork, Cork, Ireland, Little Island, Cork, Ireland

Job Description:

• Perform assigned testing and laboratory activities accurately, safely and within agreed timelines, in accordance with approved methods and procedures.
• Support the operation, calibration, maintenance and qualification of laboratory equipment and utilities.
• Document, review and report laboratory data in compliance with GMP, data integrity principles and site procedures.
• Support material release, sample scheduling and the achievement of departmental key performance indicators.
• Identify, escal ... and support the investigation of deviations, atypical results and laboratory issues, as required.
• Maintain personal training and technical competence, while contributing to knowledge sharing and team development.
• Prepare, review and maintain QC documentation, including test records, procedures and supporting records.
• Collaborate with Quality Assurance, Manufacturing and other functions to ensure QC activities are completed efficiently and business priorities are supported.
• Support internal audits, external audits and regulatory inspections, as required.
• Contribute to departmental goals, continuous improvement initiatives and cross-functional site activities.
• Maintain current knowledge of analytical methods, laboratory technologies and evolving compliance requirements.

Qualifications / Requirements:

• Level 7 in a scientific/technical discipline is required.
• Experience in the lab or similar QCA role.
• Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals.
• Performance driven,
• A team player.
• Good communicator.

Preferred Skills:

• Analytical Reasoning
• Business Behavior
• Compliance Management
• Continuous Improvement
• Controls Compliance
• Data Analysis
• Execution Focus
• ISO 9001
• Persistence and Tenacity
• Quality Control (QC)
• Quality Control Testing
• Quality Standards
• Quality Systems Documentation
• Report Writing
• Sample Testing
• Technologically Savvy

Significant Environmental, Health and Safety Considerations

All employees are required to comply with the requirements of the company’s Environmental, Health & Safety Policy, Safety Statement, associated EHS Procedures, local legislation and duties outlined in the site EHS Manual.

In line with the Safety Health & Welfare at Work Act (2005), all employees are required to:

• Take reasonable care to protect his or her own and the safety of their colleagues who may be affected by their actions.
• Comply with EHS rules and procedures at all times.
• Understand the potential EHS impact of their activities.
• Attend and participate in EHS training as required.
• Use PPE and safety equipment as required.
• Report all incidents, accidents, and near miss events.

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.
• 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
• service anniversary and recognition awards
• 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.

The anticipated base pay range for this position is:

€42,400.00 - €67,965.00