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Human Resources · 2 days ago
Quality Compliance Coordinator
Rahway, NJ
Full-time
Hybrid
Mid Level
2+ years exp
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Responsibilities
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.
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.
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.
Qualification
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Required
Associate Degree with 3yrs or more related QA field experience
Bachelor’s Degree with 2yrs or more related QA field experience
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
Company
Human Resources
We are committed to promote a work environment that is characterized by fair treatment of staff, open communications, personal accountability, trust and mutual respect.
501-1,000 employees
Funding
Current Stage
Late StageCompany data provided by crunchbase
