Clinical Quality Assurance Specialist

Job Description

Note: this is an office based role in Middleton, WI

Summarized Purpose:Provides basic level of expertise to the department in one or more specialized areas or processes in the execution of the Quality Management System (QMS). Will attend inter-departmental meetings related to the area of expertise and provide input. May serve as a QA client contact for company contracted services and contribute to policy-making decisions as a resource in area(s) of expertise.

Essential Functions and Other Job Information:

• Serves as subject matter expert for process/vendor audits or activities in area of expertise, e.g. reviews manufacturing investigations, lab investigations, root cause analysis, batch record review or Total Quality Management.

• Participates in client and regulatory inspections/audits, might represent the department, and participates in developing and tracking corrective actions.

• Provides training for department and/or laboratory staff where required.

• Reviews batch records and associated documentation for completeness and accuracy of data.

• Utilizes department checklists to evaluate content of reports and compliance with reporting criteria.

• Verifies accuracy of analytical results and sample identification; inventories and submits data to archives. Provides support for quality investigations and contracted services.

• Handles production pre and post line clearances and in-process checks as per GMP requirements.

• Provides support to the department with incoming material inspection as per GMP requirements.

• Participates in risk assessments.

• Manages set up and filing of documents.

• May mentor junior team members in area(s) of expertise.

Qualifications:

Education and Experience:

Bachelor's degree or equivalent and relevant formal academic / vocational qualificationPrevious lab or QA experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years).In some cases an equivalency, consisting of a combination 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:• Thorough knowledge of applicable GxP and appropriate regional regulations • Firm knowledge of the clinical trial process• Good knowledge of SOPs and WPDs• Excellent oral and written communication skills (including appropriate use of medical and scientific terminology)• Strong attention to detail• Effectively works independently or in a team environment• Effective problem solving skills• Solid organizational and time management skills including ability to multitask and prioritize competing demands/work load• Strong computer skills; ability to learn and become proficient with appropriate software• Proven flexibility and adaptability• Valid driver's license and ability to qualify for and maintain a corporate credit card with sufficient credit line for business travel.

Working Conditions and Environment:• Work is performed in an office, laboratory and/or GMP Depot environment.• For laboratory positions, potential 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. • Variable work hours to accommodate schedules

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 up to 50 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 multitask. • Regular and consistent attendance.

Our 4i Values:

Integrity – Innovation – Intensity – Involvement

If you resonate with our 4i values above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, submit your application – we’d love to hear from you!