What are the responsibilities and job description for the Quality Assurance Specialist 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 QA Specialist to join our Process Alliance team, supporting a pharmaceutical manufacturing team in Concord, North Carolina. This is a full-time, on-site role focused on deviation investigations in a GMP environment.
Key Responsibilities:
- Write detailed deviation reports, documenting investigations in compliance with GMP standards
- Collaborate with cross-functional teams (QA, manufacturing, QC, engineering) to gather data and support root cause analysis
- Ensure timely closure of deviations and support CAPA documentation as needed
- Participate in deviation trending and reporting to drive continuous improvement
Qualifications:
- Bachelor’s degree in a scientific or engineering or related field
- 1–2 years of experience in the pharmaceutical industry
- Experience writing or supporting GMP deviation investigations
- Packaging experience is a plus
- Quality Control Lab experience is a plus but not required
- Strong analytical and writing skills
- Familiarity with quality systems is a plus
Qualified applicants must be authorized to work in the United States on a full-time basis. Process Alliance will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.
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.