QA Support Auditor I, Laboratory Services

Job Description

• Please note this role is Office based in Middleton, WI; so must be local to the area.

• This is a support Auditor I role

The QA Auditor I assures the quality of data and reports generated by the GMP laboratory support teams including equipment and software validation (IQ/OQ/PQ) documentation, instrument maintenance and calibration reports and facility qualification documentation. Conducts internal audits to ensure compliance with established quality assurance processes, standards, global regulatory guidelines and/or client contractual obligations. Identifies and addresses non-conformance issues. Applies company policies and procedures to resolve routine issues.

Essential Functions

• Conducts a variety of internal or GMP audits and supports regulatory inspections as requested by senior management

• Participates in process audits (internal audits)

• Performs other types of QA audits or activities (facility audits, CAPA/Effectiveness Checks, nonconformances, metrology, process improvement)

• Serves as a resource to operational departments on audit or quality assurance subject matter

• Prepares and presents audit findings and/or other related information at departmental, internal operations

• Audits data for compliance with methods and standard operating procedures

• Audits analytical reports for completeness and accurate representation of the data

• Serves as a resource to operational departments on audit or quality assurance subject matter

Job Complexity

Works on problems of limited scope. Follows standard practices and procedures in analyzing situations or data from which answers can be readily obtained.

Job Knowledge

Learns to use professional concepts. Applies company policies and procedures to resolve routine issues.

Supervision Received

Normally receives detailed instructions on all work.

Business Relationships

Contacts are primarily with immediate supervisor, and other personnel in the department. Builds stable working relationships internally.

Qualifications:

Education and Experience:

Bachelor's degree or equivalent and relevant formal academic / vocational qualification; Associates' degree and relevant experience is acceptable in lieu of Bachelor's degree

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

Previous GMP experience in either Quality or Lab environment

'In some cases an equivalency, consisting of appropriate education, training, and/or directly related experience will be considered sufficient for an individual to meet the requirements of the role.'

Knowledge, Skills and Abilities:

• Familiar with applicable GxP and appropriate regional regulations

• Thorough working knowledge of SOPs and WPDs

• Excellent oral and written communication skills (including appropriate use of medical and scientific terminology)

• Strong attention to detail

• Able to work independently or in a team environment

• Strong problem solving abilities

• Strong organizational and time management skills

• Use of Microsoft Office Suite (Word, Excel, PowerPoint, TEAMS, Planner)

• Use of OneNote and SharePoint

• Basic computer skills and ability to learn and become proficient with appropriate software

• Proven flexibility and adaptability

Management Role:

No management responsibility

Working Conditions and Environment:

• Work is performed in an office and laboratory environment.

• Exposure to biological fluids with potential exposure to infectious organisms.

• Exposure to electrical office equipment.

• Personal protective equipment required such as protective eyewear, garments and gloves.

• Possible overtime

Physical Requirements:

• Ability to work in an upright and /or stationary position for 6-8 hours per day.

• Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.

• Frequent mobility required.

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

• Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.

• Ability to access and use a variety of computer software developed both in-house and off-the-shelf.

• Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.

• Frequently interacts with others to obtain or relate information to diverse groups.

• Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task.

• Regular and consistent attendance.