Quality Compliance Specialist
6 days ago
As a high-performance provider of business process solutions, facilities management, and infrastructure support services to government and commercial markets, PRWT Services is a premier minority-owned company.
SUMMARY The Quality Compliance Coordinator will support training, documentation, and communication efforts related to Quality Compliance. This role requires a strong background in quality compliance, excellent organizational skills, and effective communication abilities with previous GMP, GxP, or cGxP experience. ESSENTIAL DUTIES AND RESPONSIBILITIES include the following:GMP Quality:
• Track, manage, and report compliance-related activities in collaboration with the Quality Organization (e.g., training, compliance, audit response preparation, SOP periodic reviews, investigations, CAPAs).
• Author and/or facilitate investigations and assist in identifying appropriate corrective and preventative actions (CAPAs).
• Coordinate inspection activities and assist areas in maintaining a state of inspection readiness.
• Coordinate resolution of compliance issues in collaboration with functional areas. Documentation:
• Administer SOPs and supporting documentation (e.g., Forms, Job Aids, SOP deviations). (Provide draft templates, keep tracking databases up to date, make documents effective or inactive).
• Author/review/contribute to SOPs to ensure compliance commitments are appropriately incorporated and timelines are met.
• Assure adherence to Records Management and other Documentation system requirements. Training:
• Coordinate, develop, and maintain learning plans and assure consistency across the Organization.
• Administer the training system (request training materials to be uploaded in the system, make and verify employee, curricula, and job position data changes in the learning system, run reports).
• Monitor that functional area employees have attended mandatory/relevant training and advise management of training compliance status and related training issues.
• Other duties as assigned.
EDUCATION and/or EXPERIENCE
- Associate Degree with 3yrs or more related QA field experience - Preferred or Bachelor's Degree with 2yrs or more related QA field experience - Preferred
- Experience with GxP, cGxP training and documentation compliance
- Experience in quality, clinical development, and/or clinical supplies
- Ability to interpret policies and compliance requirements
- Demonstrated critical thinking, analytical, and problem-solving skills
- Ability to maintain a high level of confidentiality and exercise discretion
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