Manufacturing Writer

2 weeks ago


Durham NC, United States Process Alliance Full time

Company Overview: Process Alliance is a leading engineering consultancy firm dedicated to delivering innovative solutions in engineering, automation, manufacturing services, and medical devices. With a commitment to being a better model of problem solving, we have been at the forefront of providing cutting-edge engineering services to clients across the life science industry. Our team of experts thrives on solving complex challenges and driving technological advancements to meet the evolving needs of our clients.

Were hiring a Deviation Writer to join our pharmaceutical manufacturing team in Durham, NC. This full-time, on-site role is open to both early-career and experienced candidates with backgrounds in GMP manufacturing, quality support, or deviation/CAPA management. The ideal candidate will have strong technical writing skills and the ability to complete root cause analyses (RCAs) and investigations in compliance with GMP standards.

Perform and complete root cause analyses (RCAs) for assigned deviations, ensuring investigations are thorough, well-documented, and aligned with quality system expectations.
Collaborate with cross-functional teams (QA, Manufacturing, QC, Engineering, Validation) to gather information, review data, and support investigation activities.
Maintain high-quality documentation consistent with data integrity standards.

Bachelors degree in a scientific, engineering, or related field.
Pharmaceutical or GMP industry experience preferred; open to applicants with a wide range of deviation-writing or QA investigation experience.
Experience writing or supporting GMP deviation investigations.
Quality Control (QC) lab or manufacturing experience is a plus but not required.
Strong analytical, critical thinking, and technical writing skills.

Visit our website at to explore our projects, expertise, and the impact we make in the engineering and consultancy space.

We encourage applications from candidates of all backgrounds and experiences.


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