Quality Compliance & Systems Specialist I

We are seeking to hire a Quality Compliance & Systems Specialist I to join our Quality Team…

If any of the below describes you, we would love to meet you! 

JOB SUMMARY

The Quality Compliance & Systems Specialist I will report to the Manager of Compliance and Quality Systems and will be responsible for ensuring that the site Quality Systems (CAPA, Non-Conformance, Trending, Change Management) are being followed and are up to current industry standards.  The Specialist will participate in intra-departmental meetings with key stakeholders to proactively identify and address gaps in processes and drive continuous improvements within Quality.  This is a client-facing role, and the Specialist will be a key participant in Adare’s regular Quality and Auditing interactions with customers. 

RESPONSIBILITIES AND LEARNING OPPORTUNITIES

• Ensure Quality Systems (CAPA, Non-Conformance, Trending, Data Integrity, System/Process Change Control, Audit responses, etc.) compliance and drive improvements.
• Provide guidance and ensure corrective and preventive actions are adequately and timely implemented and monitor their closure and effectiveness.
• Create Annual Product Reviews for management decision making.
• Preparation and participation in client audits, fulfilling document requests, etc.
• Assist with internal quality system audits to ensure GxP practices are consistently adhered to meet safety, quality, and regulatory requirements.
• Participate in the Gemba walk program and track issues that are identified in order to bring to closure
• Proactive in continuous improvement of quality systems and procedures, including writing and revising SOPs.
• Conducts investigations to determine root cause and recommends and implements corrective, preventive action.
• Participate in Global Regulatory Agency Audits
• Assists in identifying process improvements for increased efficiencies, compliance and quality relating to the business.
• Review laboratory incidents and investigations.
• Ensure facility adherence to cGMP’s and SOP’s.
• Maintain the confidentiality of pertinent information.
• Compile and publish trend reports as needed in support of compliance procedures
• Trend, prepare and present quality metrics for consumption by senior management
• Work as collaborative partner of the Quality Assurance team to meet company, departmental, and individual goals as outlined by management.

REQUIRED SKILLS AND QUALIFICATIONS

• BS/BA degree; prefer 2 years of dynamic Compliance, Quality Assurance or Quality Control experience in the life sciences industry
• Advanced knowledge GMP requirements
• Understanding of Quality Systems pertaining to a bulk pharmaceutical, solid oral dosage manufacturing and packaging environment is preferred.
• Working knowledge of documentation guidelines and practices.

Adare Pharma is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status.

PRINCIPALS ONLY
NO AGENCIES OR THIRD PARTIES