Senior QA Specialist - II

Proclinical is currently recruiting for a Senior Quality Assurance Specialist - II position with an international biopharmaceutical company located in Frederick, MD. Successful candidate will perform a wide variety of activities to ensure compliance with applicable quality objectives and regulatory requirements.

Job Responsibilities:

• Review and approve validation and functional areas documents.
• Review and improve existing quality procedures, process workflows, and performs process mapping of QA and Quality Systems Operations. Identifies areas of improvement for efficiency and compliance and leads implementation efforts in collaboration with cross-functional stakeholders.
• Perform a wide variety of activities to ensure compliance with applicable quality objectives and regulatory requirements.

Skills and Requirements:

• Bachelor's degree in chemistry, biology or related scientific field.
• 7+ years of relevant experience in a GMP environment related field and a BS or BA.
• 5+ years of relevant experience and a MS.
• Proficient in GMPs.
• Expertise in Quality Systems and cGMP standards applicable to commercial products and operations.
• An accountable team player and leader who is detail and quality-oriented with solid understanding of quality assurance principles, systems, methods and procedures.
• Excellent attitude with good verbal, interpersonal communication, excellent judgment and multitasking skills who can adapt to changing priorities.
• Possess critical thinking skills when making sound quality decisions based on risk management and available data.
• Technical writing skills for creating and approving Quality Systems SOPs and Training documents to ensure quality objectives are met.
• Ability to work independently and effectively coach peers in a high-paced environment with tight timelines, while maintaining accuracy and quality.
• Demonstrates ability to effectively manage multiple projects/priorities.
• Demonstrates working knowledge and good proficiency in Microsoft Office application.
• Proficient in application of QA principles, concepts, industry practices, and standards.
• Demonstrates ability to effectively manage multiple projects/priorities.
• Demonstrates excellent verbal communication, technical writing and interpersonal skills.
• Demonstrates working knowledge and good proficiency in Microsoft Office applications.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Brendan Thalheimer at (+1) 215-531-5299 or upload your resume on our website - www.proclinical.com.

A full job description is available on request.

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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