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.
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