Job Description

Job Title: Deviation Investigation Writer/Associate

Location: Concord, NC

Type: 6-Month Contract (Potential for Extension or Conversion)

Schedule: Monday–Friday, 8:00 AM – 5:00 PM

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.

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