As one of the nation’s premier minority-owned companies, we are a high performance provider of business process solutions, facilities management and infrastructure support services to government and commercial markets.
SUMMARY
The Quality Compliance Coordinator will be responsible for supporting training, documentation, and communication efforts related to Quality Compliance. The Quality Compliance Coordinator will be familiar with and have a background in quality compliance, strong organizational skills, and excellent 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 the SOPs and supporting documentation (e.g. Forms. Job Aids, SOP deviations). (Provide draft template, keep tracking database up to date, make docs 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, development 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 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 high level of confidentiality and exercise discretion.
We proactively offer employment and advancement opportunities for individuals from all backgrounds. By engaging in a diverse workforce and using a diverse groups of suppliers, we position ourselves to successfully compete in a 21st Century global economy.
Other details
