- Company Name
- OmniaBio
- Job Title
- Compliance Associate (Manufacturing, 12-month contract)
- Job Description
-
**Job Title:** Compliance Associate (Manufacturing – 12‑Month Contract)
**Role Summary:**
Support a GMP‑compliant biomanufacturing environment by managing documentation, training, audits, and investigations. Lead cross‑functional quality initiatives, ensuring adherence to regulatory frameworks (FDA, Health Canada, EMA, ICH‑Q7, ISO) and internal SOPs.
**Expectations:**
- Deliver on all compliance deliverables within agreed timelines.
- Maintain high data integrity (ALCOA principles) and accurate record keeping.
- Effectively communicate with stakeholders and enforce GMP standards.
- Demonstrate flexibility to accommodate shift work, weekends, and emergency calls.
**Key Responsibilities:**
- Review and enforce GMP/Good Documentation Practice (GDP) and departmental procedures.
- Generate KPI adherence reports and maintain metrics in SAP.
- Manage vendor/supplier quality controls and support the vendor management system.
- Initiate, lead, and complete investigations, deviation, and incident reports.
- Conduct impact assessments, change control (CR) reviews, and CAPA planning.
- Oversee departmental SOP review cycle, coordinating SMEs, revising SOPs, and preparing CR documentation.
- Lead risk assessments, mitigation strategies, and cross‑functional quality projects.
- Coordinate training programs: identify gaps, deliver GMP training, review test results.
- Prepare and serve as SME for internal, client, and regulatory audits.
- Identify compliance risks, develop corrective/preventative action plans, and monitor closure of audit findings.
- Perform root cause analysis and maintain electronic QMS.
- Support special projects, cross‑functional duties, and other assigned tasks.
**Required Skills:**
- Strong understanding of GMP, GDP, CAPA, change control, and audit processes.
- Proficiency with SAP, electronic QMS, and root‑cause analysis tools.
- Excellent written and oral communication; ability to present training and audit findings.
- Detail‑oriented, analytical, and capable of independent problem solving.
- Ability to work cross‑functionally and manage multiple priorities.
- Knowledge of cell & gene therapy regulatory requirements (FDA, Health Canada, EMA, ICH‑Q7, ISO).
- Familiarity with environmental monitoring, equipment maintenance, and facility automation systems.
- Experience with ALCOA principles and data integrity.
**Required Education & Certifications:**
- Bachelor’s degree in Life Sciences, Pharmacy, Engineering, or related field.
- Certifications in GMP, CAPA, or Quality Assurance preferred.
- Knowledge of ICH, FDA, EMA, or ISO standards; advanced certifications (e.g., Certified Quality Engineer, CQE) advantageous.