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Sr QA Specialist - II

Company: Unicon Pharma
Location: Rockville
Posted on: May 18, 2020

Job Description:

Location: Frederick, MD Duration: 06 Months-Contract Description: Specific Responsibilities and skills for Position: Reviews and approves validation and functional areas documents. Reviews and improves 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. Performs a wide variety of activities to ensure compliance with applicable quality objectives and regulatory requirements. Education and Specific Skills: Bachelor's degree in chemistry, biology or related scientific field with 7+ years of relevant experience in a GMP environment or Masters degree with 5+ years of relevant experience. 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. Knowledge and other Skills: Proficient in GMPs. 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.

Keywords: Unicon Pharma, Rockville , Sr QA Specialist - II, Other , Rockville, Maryland

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