QA Auditor II

Description

This is an associate-level quality assurance auditing role in the clinical auditing area, focused on compliance and quality.

The role is based in an office and follows a standard Monday to Friday schedule.

Responsibilities

• Carry out routine audits for clients, internal teams and GxP requirements.
• Support non-complex process audits, and lead them where the work is not complex.
• Take on other QA audits and tasks, such as database audits, clinical study report reviews, sample results tables, facility audits and process improvement work.
• Advise operational departments on audit and quality assurance questions.
• Help prepare audit findings and related documentation.

Requirements

• A bachelor's degree or an equivalent formal academic or vocational qualification is needed. An associate degree plus relevant experience can be used instead.
• Earlier lab or QA experience giving the knowledge, skills and abilities for the job, comparable to 1 year.
• A mix of suitable education, training and directly related experience may be accepted in place of the standard requirements.
• Introductory knowledge of applicable GxP and regional regulations.
• Working knowledge of Good Manufacturing Practice (GMP) requirements.
• Working knowledge of SOPs and WPDs.
• Preferred: previous experience working in a laboratory.
• Strong oral and written communication, including accurate use of medical and scientific terms.
• Careful attention to detail.
• Ability to work alone or as part of a team.
• Sound problem-solving skills.
• Good organization and time management.
• Basic computer skills, with the ability to learn and become proficient in relevant software.
• Proven flexibility and ability to adapt.
• 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

Work takes place in an office, laboratory and/or clinical setting.

Possible exposure to biological fluids and infectious organisms.

Regular use of electrical office equipment.

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

Upright and/or stationary work for 6-8 hours per day.

Repetitive fast, simple movements of the fingers, hands and wrists with both hands.

Frequent movement around the workplace.

Occasional crouching and stooping, and frequent bending and twisting of the upper body and neck.

Lifting and carrying of light to moderate loads, including luggage and a laptop, up to 15-20 lbs.

Use of a range of computer software, both developed in-house and off the shelf.

Clear communication, and listening to and understanding spoken information and ideas.

Frequent contact with diverse groups to share or gather information.

Handling a wide range of tasks with changing demands and little predictability, including working under stress and juggling several tasks at once.

Regular and consistent attendance.