Deviation Quality Remediation Team – Lead & Writers (Contract Project)

Location: Greater Baltimore Area / Hunt Valley, MD (100% On-Site)

Duration: 6 to 18 Months Contract (Strictly short-term contract project work)

Core Hours: Mon–Fri, 8AM–5PM (Standard Business Hours)

Opportunity & Opportunity Dynamics

Workforce Genetics is assembling a high-impact, 5-person contingent quality team to support a premier pharmaceutical manufacturing facility in the Greater Baltimore Area during a major operational transition. Following a recent corporate acquisition and system integration phase, the site is executing an intensive quality remediation project to address an active backlog of approximately 400 open investigations, deviations, and CAPAs. The primary immediate objective is an aggressive clearance of 70 to 80 high-priority deviations preventing product release.

We are actively recruiting 1 Project Lead and 4 Technical Writers for this dedicated, on-site initiative.

Role Breakdown & Specific Requirements:

• Remediation Project Lead (1 Role)
• Experience Required: Minimum 5–6 years within biopharma/GMP compliance environments, specifically showing history leading quality writing groups or tracking delivery timelines.
• Scope: Serves as a hands-on manager who tracks daily completion metrics, identifies systemic workflow blockers, updates operational leadership, and coordinates directly with global QA teams while actively assisting in writing deviations.
• Deviation Writers (4 Roles)
• Experience Required: Minimum 3–4 years of technical writing experience explicitly focused on deviation and CAPA investigations within a cGMP manufacturing facility.
• Scope: Focuses heavily on tactical execution—conducting manufacturing staff interviews across shifts, executing systematic root-cause analysis, and writing comprehensive investigation reports to clear the floor backlog.

General Candidate Profile & Technical Requirements

• Technical Mastery: Proven expertise in systematic root-cause analysis (RCA) methodologies and standard cGMP technical writing.
• Domain Context: Strong preference for professionals with eclectic experience across upstream processing, downstream processing, and fill lines. Familiarity with Oral Solid Dose (OSD) manufacturing and visual inspection processes is a significant advantage.
• Background Flexibility: 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.