QA Auditor III

Description

The company is a large life sciences organisation. This role sits in quality assurance and works on the Standard Monday to Friday schedule in an office setting.

The QA Auditor III leads complex audits that span one or more departments, internal or external, checking compliance with the company's quality processes, recognised standards, global regulatory guidance and client contract terms. The role finds quality and regulatory problems, works out their root causes and proposes ways to fix them. You may also carry out technical document reviews and other GxP work for projects or company processes, write final audit reports for management, and plan and deliver paid quality services to clients and projects. You may act as the main client contact.

Responsibilities

• Run client, internal or GxP audits and regulatory inspections when senior management asks for them.
• Lead targeted audits of sites, facilities, vendors and subcontractors.
• Advise project teams and external clients on GxP matters.
• Lead process audits, and join more complex system audits as co-auditor.
• Carry out other QA audits and activities, such as database audits, clinical study report audits, sample results table reviews and process improvement work.
• Act as the go-to contact for operational departments on audit and quality assurance questions.
• Present audit findings and related information to departments, operations teams and clients.
• Mentor and guide junior auditors.

Requirements

• A bachelor's degree or equivalent, plus a relevant formal academic or vocational qualification.
• Prior QA work that gives you the knowledge, skills and ability to do the job, roughly 5+ years.
• Where appropriate, a mix of education, training and directly related experience may be accepted in place of a standard requirement.
• In-depth knowledge of GxP and the relevant regional research regulations and guidelines.
• A record of leading project-based, internal GxP and vendor audits to the standard management expects.
• Working knowledge of Good Manufacturing Practice (GMP) requirements.
• Experience in a laboratory setting is preferred.
• Excellent spoken and written communication.
• Strong skills in problem solving, risk assessment and impact analysis.
• Solid root cause analysis experience.
• Above-average negotiation and conflict management skills.
• Able to juggle multiple tasks and reprioritise competing workloads.
• A valid driver's license, and the ability to qualify for and keep a corporate credit card with a credit line large enough for business travel.

Conditions

The work takes place in an office, laboratory and/or clinical environment.

You may be exposed to biological fluids and potentially infectious organisms.

You will work around electrical office equipment.

Personal protective equipment is required, including protective eyewear, garments and gloves.

The company welcomes applicants from all backgrounds and treats everyone equally.

Benefits

• You join a global team where collaboration and professional development are part of daily work, and your contributions have visible impact.