Quality Assurance Compliance Specialist III
Proclinical is seeking a Quality Assurance Compliance Specialist III for a cutting-edge biotech company located in Gaithersburg, MD.
Must be eligible to work in the US.
- Provide Quality technical support to the internal organization as well as cross-functional teams working through data reviews for product development, technology transfer, stability, and/ or GMP testing activities both internally and at our contract manufacturing, testing sites, and partners.
- Support the quality impact assessments/risk assessments for deviations, OOS investigations, and change controls related to manufacturing and testing activities and provide the required quality assessment and approval for these quality records.
- Support technical teams by providing QA input, review, and approval to study designs, protocols, technical reports, and new program implementations.
- Support Quality Control during regulatory inspections and in maintenance of a state of inspection readiness.
- Maintain working knowledge of documentation (including Quality Manual, Policies and SOPs) and relevant GxP regulations and guidelines related to US and EU compliance.
- Stays current and is an internal subject matter expert for changes in GxP expectations, including FDA, EU and other relevant foreign regulatory bodies, guidance documents (i.e.: ICH, PTC, ISPE, etc.), and best industry practices.
- Effectively collaborates 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.
- Extensive experience in laboratory controls including analytical method validation, routine and stability testing, investigations, and change controls.
- 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 to manage multiple priorities, adapt and maintain adherence to timelines
- Demonstrated technical knowledge
- Demonstrated ability to manage process improvement projects
- Demonstrated knowledge of GMP, GLP, GCP and GCLP expectations
- The ability to keep colleagues and management apprised of projects and status independently and appropriately; to anticipate future needs based on prior experiences.
- The accountability to reach established goals or targets for moderately complex tasks with the involvement of immediate teammates without compromising commitments
- The capability to assist other team members in a small number of areas and learns additional knowledge cooperatively; to build influence by completing tasks and presenting new ideas; to contribute to cross-functional work; to build relationships internally and coordinates work with others
- The position may require periodic weekend/evening work.
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.