What are the responsibilities and job description for the Deviation Writer position at Process Alliance?
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.
Overview:
We’re 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.
Key Responsibilities:
- Write clear, detailed, and compliant deviation reports in accordance with GMP and internal SOPs.
- 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.
- Ensure timely deviation closure and support development and documentation of CAPAs as needed.
- Participate in deviation trending, metrics, and reporting to support continuous improvement efforts.
- Maintain high-quality documentation consistent with data integrity standards.
Qualifications:
- Bachelor’s 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.
About Our Culture:
At Process Alliance, we strive to be a better model for how problems are solved, and solutions are delivered. We believe in providing a supportive and inclusive work environment where employees can thrive both personally and professionally. Join our team and be part of a company that is shaping the future of engineering solutions.
Learn more about us:
Visit our website at www.processalliance.com to explore our projects, expertise, and the impact we make in the engineering and consultancy space.
Process Alliance is an equal opportunity employer. We encourage applications from candidates of all backgrounds and experiences.
