Quality Systems Specialist

Adare Pharma Solutions Recruiting Team•Vandalia, OH

About The Position

The Quality Systems Specialist is an essential part of the Quality Assurance team and will be responsible for ensuring that the site Quality Systems (CAPA, Non-Conformance, Trending, Change Management, Complaints) are being followed and are up to current industry standards. In addition, the Quality Systems Specialist is expected to ensure execution of policies and practices for compliance with DEA Controlled Substance regulations, requirements, and expectations.

Requirements

BS/BA degree; 5+ years of dynamic Quality Assurance or Quality Control experience in the life sciences industry
Advanced knowledge GMP requirements
Must possess knowledge of DEA regulations and industry guidance’s, policies, and procedures pertaining to the DEA Controlled Substance.
Excellent document quality.
Ability to analyze and synthesize.
Excellent interpersonal written and oral communication skills.
Proficient in Microsoft Office including advanced skills in Excel (Pivot tables, Vlookup, Macros, If Statements, Formulas).
Ability to coordinate, contribute to, and work within a cross-functional team.

Nice To Haves

Understanding of Quality Systems pertaining to a bulk pharmaceutical, solid oral dosage manufacturing and packaging environment is preferred.
Operational knowledge of European GMPs

Responsibilities

Ensures Quality Systems (CAPA, Non-Conformance, Trending, Data Integrity, Customer Complaints, Change Control, etc.) compliance and drives improvements.
Provide guidance and ensure corrective and preventive actions are adequately and timely implemented and monitor their closure and effectiveness.
EDMS/EQMS Superuser
Create Annual Product Reviews for management decision making.
Investigate Customer Complaints through follow-up and resolution.
Interact with Customer’s Quality associates to fulfill client needs.
Participate in Customer/Regulatory audits.
Audits quality systems and manufacturing practices and ensures that products are produced to specification and that all documentation requirements are consistently adhered to meet safety, quality, and regulatory requirements.
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, preventative.
Collaborate with all departments within the company as required.
Ensure facility adherence to cGMP’s and SOP’s.
Understands DEA regulations and updates policies, procedures, and practices for compliance with applicable rules and regulations.
Assists with DEA compliance training.
Monitor the use of DEA 222 order forms for compliance with DEA requirements.
Review cGMP documentation related to controlled substances.
Assist with inventory accountability and reconciliation for controlled substances.
Coordination of controlled drugs destructions in accordance with DEA regulations.
Maintain the confidentiality of pertinent information.
Trend, prepare and present quality metrics to senior management.
Upholds Company policies, including the Professional Conduct Policy and Prohibition Against Harassment Policy, and the Business Ethics and Conduct Code.