Opportunity
Workforce Genetics is assembling a high-impact, 4-person contingent quality team to support a premier pharmaceutical manufacturing facility in the Greater Baltimore Area. The site is executing an intensive quality remediation project to address an active backlog of open investigations, deviations, and CAPAs. The primary immediate objective is an aggressive clearance of high-priority deviations.
We are actively recruiting 4 QA Deviation Technical Writers for a 6+ month on-site quality remediation project.
Responsibilities:
- In this role you will draft comprehensive deviation investigation reports, which includes conducting detailed root-cause investigations, manufacturing staff interviews, and interfacing with floor teams to clear the tactical backlog.
Requirements & Qualifications
- Experience: Minimum 3–4 years of technical writing experience explicitly focused on deviation investigations within a cGMP environment.
- Core Competency:
- Strong technical writing, systematic root-cause analysis (RCA) methodology, and robust deviation/CAPA investigation skills and experience supporting aseptic quality operations are mandatory.
- Proven expertise in deviation/CAPA investigations, systematic root-cause analysis (RCA) methodologies and standard cGMP technical writing.
- Strong preference for professionals with experience on fill lines, with upstream processing and downstream processing also acceptable if you have strong aseptic quality experience.
- Familiarity with Oral Solid Dose (OSD) manufacturing and visual inspection processes is a significant advantage.
- Education: A formal academic degree is not strictly required; technical mastery, an ability to write cleanly under tight compliance timelines, and a strong history on the manufacturing floor are the primary drivers for selection.
Core Hours:
- Mon–Fri, 8AM–5PM (Standard Business Hours; scheduling flexibility to interface with off-shift personnel during day hours)