QA Support Auditor I, Laboratory Services

2 weeks ago

Middleton, United States Thermo Fisher Scientific Full time

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)
- 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

**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.

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