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