QA Compliance Coordinator

2 weeks ago

New York, United States Astrix Inc Full time

Direct hire opportunity 1st shift M-F (onsite role, working from home on Fridays after completing training) Salary: $55-65K

Job Purpose: Responsible for quality oversight of products and processes as well as routine product support activities in the Production to ensure that all aspects of areas oversight comply with cGMP and regulatory requirements.

Responsibilities: Maintaining of the training program Reports, tracks, and follows up on deficiencies noted, including assessments, audits, investigations, and overall site performance. Establishes metrics and KPI’s for Customer Complaints, audit findings (external and internal) and non-conformances to determine corrective actions as needed. Provides audit responses to external audit findings. Guidance in the implementation of compliance and quality improvement initiatives. Audits processes and controls, as well as cGMP and FDA requirements, to ensure CAPA’s are effective and product quality and performance conform to established standards. Troubleshoots quality problems, provides thorough and practical assistance in the resolution of process / product non-conformance events, and assists in the development of corrective actions to prevent reoccurrence, leveraging Quality Systems. Drives resolution of quality issues through quality investigations and root cause analysis. Additional responsibilities may include: Review of process / product-related documentation

Job Relevant Information: The Compliance Coordinator is responsible for performing customer complaints investigations, training program maintenance, document review, procedure changes, supporting internal and external audits, and other quality projects with the direction of the Compliance Supervisor.

Qualifications, Experience & Skills BS/BA Degree or Equivalent Minimum of 3 years of experience in quality for Cosmetic, Drug industry or equivalent Experience in performing customer complaints investigations and internal audits Knowledge of cGMPs Good Computer and Communication Skills Comfortable presenting training material in front of groups of employees Fluent in English (reading & speaking) Cooperative Reliable Attendance Capable of collecting, understanding, analyzing, and reporting data for continued process improvement

Preferred Experience: Certified Quality Auditor ISO 22716 environment

Job-Specific Skills: Proficiency in Microsoft Office Suite Displays flexibility, calmness, confidence, integrity and “can do” attitude Excellent communication and organizational skills Customer service attitude Good listener and attention to detail Ability to multi-task and prioritize

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