Quality Assurance Compliance Specialist III job in Gaithersburg, USA

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First Name*

Last Name*

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Job type: Permanent

Discipline: Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), Good Laboratory Practice (GLP)

Location: United States

This vacancy has now expired. Please see similar roles below...

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.

Job Responsibilities:

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 k.williams@proclinical.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.

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