Job Title: Deviation Investigation Writer/Associate
Location: Pleasant Prairie, WI
Duration: 3-Month Contract (Potential of Extension)
Overview:
We are seeking two detail-oriented and driven professionals to join a dynamic manufacturing
operations team as Deviation Investigation Writers. These individuals will play a critical role in
supporting quality compliance by documenting and investigating deviations—unexpected events that
impact product quality, safety, or regulatory standards.
Key Responsibilities:
- Ghostwrite deviation investigation reports on behalf of technical staff, including operators and engineers.
- Collaborate with subject matter experts to gather information and draft clear, audit-ready documentation.
- Support root cause investigations (RCI) and contribute to continuous improvement efforts.
- Assist in managing deviations across various manufacturing areas, including filling, inspection robotics, and process operations.
- Ensure documentation meets regulatory standards and is easily understandable by auditors and cross-functional teams.
Required Qualifications:
- Proven experience in technical writing, preferably in a regulated or manufacturing environment.
- Background in quality assurance, engineering, or a related technical field.
- Ability to quickly learn complex manufacturing processes and translate them into clear, structured documentation.
- Strong analytical and communication skills.
- Comfortable working independently and collaboratively in a fast-paced setting.
Preferred Qualifications:
- Experience writing deviation investigation reports or supporting root cause analysis.
- Familiarity with manufacturing environments such as pharmaceutical, chemical, or food production.
- Understanding of parenteral manufacturing processes is a plus, but not required.
