QA Auditor I - Ireland (Athlone)

Thermo Fisher Scientific; Ireland; On-site; EUR 45,000 - 60,000; Full time

Job summary

A global scientific company is seeking a QA Auditor for their labs in Athlone, Ireland. This full-time role involves auditing laboratory data for compliance with SOPs and reporting findings. Ideal candidates will have a Bachelor's degree and 3-5 years of QA or lab experience. Strong knowledge of GxP regulations and excellent communication skills are essential. The position allows for remote work with some on-site requirements.

Qualifications

• 3-5 years of previous QA or lab experience.
• Ability to perform audits based on GxP regulations and SOPs.

Responsibilities

• Audits laboratory data for compliance with methods and standard operating procedures.
• Audits sample result tables and analytical reports for completeness and accuracy.
• Assists in the preparation of audit findings.

Skills

GxP knowledge

Regulatory compliance

Oral communication

Written communication

Problem-solving

Risk assessment

Negotiation skills

Conflict management

Flexibility

Education

Bachelor's degree or equivalent

Job description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.

We are seeking a QA Auditor (I) for our Labs in Athlone, Ireland. The role is permanent and full-time. The position can be mostly home-based but with a requirement to be on site in Athlone as per business need (approx a few days per month).

A day in the life:

1. Audits laboratory data for compliance with methods and standard operating procedures and reports findings.
2. Audits sample result tables and analytical reports for completeness and accuracy, and reports findings.
3. Serves as a resource to operational departments on audit or quality assurance subject matter.
4. Assists in the preparation of audit findings and/or other related information.

Keys to success:

Education and Experience:

1. Bachelor's degree or equivalent.
2. Previous QA or lab experience that provides the knowledge, skills, and abilities to perform the job (comparable to 3-5 years).

Knowledge, skills, and abilities:

1. Familiar with applicable GxP and regional regulations.
2. Ability to perform GxP audits based on SOPs and applicable FDA regulations, ICH guidelines, and other relevant standards.
3. Ability to independently review study documents for compliance with regulatory requirements or organizational procedures.
4. Achieves acceptable standards of quality and meets timelines for QA deliverables and reports.
5. Excellent oral and written communication skills, including scientific terminology.
6. Strong problem-solving, risk assessment, and impact analysis abilities.
7. Proficient in negotiation and conflict management.
8. Flexible and capable of multi-tasking and prioritizing workload.

Our Mission is to enable our customers to make the world healthier, cleaner, and safer. Join our team of 100,000+ colleagues sharing values of Integrity, Intensity, Innovation, and Involvement. We work together to accelerate research, solve scientific challenges, drive innovation, and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences and perspectives are valued.