Senior Specialist, Quality R&D

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 and commercial manufacturing 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 Senior Specialist, R&D Quality to join our Quality team…

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

Job Summary

The Senior Specialist R&D Quality reports to the Manager of R&D Quality and supports Research and Development by being a dedicated quality resource with focus on pre-commercial GMP product.

Responsibilities And Learning Opportunities

• Support the R&D department in the creation or evaluation of department SOP’s to drive efficiency and quality by design.
• Ensures Quality Systems (CAPA, Non-Conformance, Trending, Data Integrity, Customer Complaints, Change Control, etc.) compliance and drives improvements specifically for R&D.
• Provide guidance and ensure corrective and preventive actions are adequately and timely implemented and monitor their closure and effectiveness.
• Supports stability program including but not limited to pulling samples, review and approval of stability documentation, and use of the electronic stability information management system.
• Reviews and approves master batch records for non-commercial GMP batches (clinical batches, tech transfer batches for example)
• Reviews and approved Design of Experiment and Critical Process Parameter Reports
• Reviews and approves all quality related documentation produced by R&D, including sampling protocols, stability protocols, test method qualification and validation reports.
• Reviews and approves investigations generated by R&D
• Participates in internal audits of the R&D department
• Interact with Customer’s Quality associates to fulfill client needs.
• Participate in Customer/Regulatory audits as needed
• Is a backup resource to the QA team that focuses on commercial product by releasing commercial batches, writing and approving investigations as needed by the Quality Director
• Conducts investigations to determine root cause and recommends & implements corrective, preventive.
• Collaborate with all departments within the company as required.
• Ensure facility adherence to cGMP’s and SOP’s with special focus on R&
• Assist with inventory accountability and reconciliation for controlled substances.
• Coordination of controlled drugs destructions in accordance with DEA regulations.
• Other duties as assigned
  
  

Required Skills And Qualifications

• BS/BA degree from a four-year accredited university or college.
• 8 years’ of related experience preferred.
• Advanced knowledge GMPs specifically clinical GMP’s
• Understanding of Quality Systems pertaining to a bulk pharmaceutical, solid oral dosage manufacturing and packaging environment is preferred.
• Operational knowledge of European GMPs.
• Excellent document quality.
• Able to prioritize duties and manage multiple activities from start to finish with minimal supervision.
• Exceptional attention to detail and excellent organizational skills.
  
  

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