Quality Systems Specialist

Are you ready to join a growing, global drug development and manufacturing organization that puts people first? Come to Adare! We work closely with our pharmaceutical industry partners during all phases of drug development with a mission of improving the lives of patients and medicines essential to people all over the world. Each role and every department within Adare offer you a unique, customized experience with a chance to make a real impact, and is critical to our success. With the help of people like you dedicated to our mission, Adare is transforming lives by transforming drug delivery!

Join our mission at Adare !

What can Adare offer you?

• Medical/dental/vision/life – low employee premiums
• 401k with a highly competitive match
• Generous PTO, including floating holidays
• Career growth and internal opportunities
• Tuition reimbursement
• Relocation assistance
• Performance-based bonus
• Employee Recognition Programs

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

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

JOB SUMMARY

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

RESPONSIBILITIES AND LEARNING OPPORTUNITIES

• 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.

REQUIRED SKILLS AND QUALIFICATIONS

• BS/BA degree; 5+ years of dynamic 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.
• Operational knowledge of European GMPs
• 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.

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*

You should be proficient in:

• 5 Why (Root Cause Analysis Method)
• FDA Regulations
• Pharmaceuticals