Quality Systems Associate

POSITION TITLE

Quality Systems Associate Purpose This is a hands-on support role for the Quality Control Unit (QCU) and QA Manager. The individual in this role will help maintain and manage controlled documents and workflows within an electronic document management system (Benchling) and a quality/training system (MediaLab). This role is highly detail-oriented and execution-focused, supporting quality systems, study operations, and audit readiness in a GxP-regulated environment. Overview Are you interested in working in a company setting with a growing group of enthusiastic, hard-working, and supportive individuals? Then consider working at DivergeTSL. Diverge works with biotech and pharmaceutical companies around the world to assist with their drug development efforts. We conduct pre-clinical and clinical trial-support studies for companies that do not have laboratories or need extra laboratory support. Why work at DivergeTSL? We offer competitive compensation packages including medical, dental and vision benefits, and access to health savings accounts, long and short-term disability, voluntary life insurance, 401(k) with company match. We also offer annual bonuses and, most importantly, a friendly, fun, and supportive work environment.

Salary range:

$55,000-70,000, plus annual performance bonus Primary Functions

• Document Control & Quality Systems Update, review, route, and approve SOPs, forms, and controlled documents throughout the document lifecycle Maintain document control systems and ensure version control and audit readiness Collaborate with document owners to ensure systems operate efficiently and effectively Perform filing, scanning, organization, and archival of controlled documents
• QA & Compliance Support Support internal and client audits, including document retrieval and response coordination Assist with investigations, deviations, and corrective actions Ensure compliance with company SOPs and GxP standards
• Study & Operational Support Assist with study documentation and tracking Perform sample blinding activities Coordinate cross-functional workflows across teams
• Archivist Fulfill the role of DTSL's Archivist Maintain and verify electronic access and permissions Archive/unarchive physical and digital study data as required Required qualifications:
• Bachelor's degree (STEM preferred) with 1-3 years of relevant experience, OR equivalent combination of education and experience
• Demonstrated ability to perform detail-oriented, process-driven work with a high degree of accuracy
• Strong attention to detail and organizational skills
• Ability to manage multiple priorities in a fast-paced environment
• Strong written and verbal communication skills
• Ability to work both independently and collaboratively
• Experience with document management systems (DMS)
• Experience with

ELN/LIMS

systems (Benchling preferred)

• Experience with quality/training systems (MediaLab preferred) Preferred qualifications:
• Experience in a GLP/GxP-regulated environment
• Experience supporting audits
• Familiarity with

FDA 21 CFR

Part 11 Application

• Send cover letter and resume to jtetzlaff@divergetsl.com Trial Period
• All new hires are subject to a 90-day introductory period, during which both the employee and Diverge TSL can assess overall fit for the role.

Organizational Structure Building:

Global Water Center, 247 West Freshwater Way, Milwaukee, WI Reports to: Quality Assurance Manager (Paul Krakau)

Direct Reports:

None Collaborates with: All company employees

Specifications Minimum Required Education:

Bachelor's degree (STEM preferred) plus 1-3 years of experience Minimum Required Experience 1

• 3 years experience in a regulatory environment FLSA Status Exempt position Workweek Full-time role 40 hours per week during regular business hours (9:30am
• 5:30pm, one 30-minute lunch break, two 15-minute breaks) Work location This is a fully onsite position based in Milwaukee, Wisconsin. Job Scope Complexity
• initiative and occasional judgment required Impact
• errors may cause damage; work requires regular attention to accuracy Autonomy
• performs work without constant supervision; expected results are specifically outlined Communication
• proactively provides information to others; ensures appropriate dissemination of information Responsibility
• assists others to ensure proper completion of work Confidentiality
• expected to work with confidential information and maintain its confidentiality Leadership
• none Physical Requirements Work requires occasionally lifting moderate weight materials, standing, or walking continuously.

Risk Potential Possible exposure to hazards such as dust, fumes, or extreme temperatures, airborne or blood borne pathogens, extreme temperatures, or allergens. Proper training and safety equipment will be provided. Sensory Acuity Ability to detect and translate speech or other communication required. May occasionally require the ability to distinguish colors and perceive relative distances between objects. Work Environment This position primarily takes place within a laboratory setting, involving both hands-on work and computer-based tasks. The Laboratory Assistant will interact with researchers, scientists, and other laboratory and office staff regularly. The role will require standing, lifting, and working with chemicals and equipment, following appropriate safety measures. Occasional exposure to dust, noise, temperature changes, or contact with water or other liquids. Work is performed in an environmentally controlled environment.

Pay:

$55,000.00

• $70,000.

00 per year

Benefits:

401(k) 401(k) matching Dental insurance Disability insurance Employee assistance program Employee discount Flexible schedule Flexible spending account Health insurance Health savings account Life insurance On-the-job training Paid jury duty Paid time off Parental leave Professional development assistance Retirement plan Vision insurance

Work Location:

In person