QA Specialist III, Supplier Quality and Compliance
Proclinical is seeking a Quality Assurance Specialist III, Supplier Quality and Compliance for a cutting-edge biotech company located in Gaithersburg, MD.
The Quality Assurance Specialist III- Supplier Quality & Compliance will be primarily responsible for supporting the implementation of GxP requirements to ensure compliance across the network. This position reports directly to the Senior Director, Global Quality Systems and Compliance.
Must be eligible to work in the US.
- Evaluate and present solutions on complex issues with minimal input from senior staff.
- Review, track, and trend routine quality data.
- Perform quality review/assessment for new suppliers and service providers.
- Execute supplier complaint process with routine reports to management, assesses supplier's qualification status and communicates potential risks.
- Prepare KPIs and understand how they add value in satisfying compliance questions.
- Support inspection readiness activities across the network.
- Support negotiations and ensure Quality Technical Agreements (QTAs) are in place with suppliers/vendors prior to use.
- Identify and support continuous improvement efforts across the quality organization.
- Maintain working knowledge of documentation (including Quality Manual, Policies and SOPs) and relevant GxP regulations and guidelines related to US and EU compliance.
- Effectively collaborate and communicate with departments across the company to analyze and resolve technical issues in accordance with appropriate quality standards.
Skills and Requirements:
- Bachelor's Degree in Biology, Chemistry, Engineering, or related field with 8+ years' experience in the Pharmaceutical/Biotech/Device industry or equivalent experience/education.
- 6+ years of experience in a Quality organization
- 3+ years industry experience in an auditing role
- Excellent understanding of Quality Assurance systems
- Strong knowledge foundation of FDA and EMA regulations regarding the manufacture of biologics and medical device/combo product (CFR 210, 211, and 820, 610).
- The ability to organize, prioritize and deliver tasks & projects with a sense of urgency.
- Excellent communication skills both verbally and written; and with various organizational levels internally and externally.
- Capable of managing multiple priorities, adapt and maintain adherence to timelines.
- Individual must be willing to travel domestically and internationally (15%), as needed.
- Prior experience must include 4 years of collaborative clinical research activity, supply chain, GxP audit support; writing and reviewing SOPs, protocols, and data; working with GCP, GVP, GLP, and GCLP regulations and regulatory bodies including the FDA, EMA, MHRA or other national health authorities; and, performing data analysis for trends and root-cause analysis of critical and major challenges to make decisions in terms of compliance.
If you are having difficulty in applying or if you have any questions, please contact Kylie Williams at +(1) 267-523-2542 or email@example.com.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.