The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
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The Quality Specialist/Manager will be responsible for establishing, maintaining, and performing a wide variety of Quality System activities in support of internal GMP manufacturing and QMS activities for human-tissue derived products. Reporting directly to the Vice President of Quality, the applicant is expected to provide leadership for maintaining and enhancing, in a phase appropriate manner, the cGxP quality system and processes such as Change & Document System Control, Deviation Management & Investigation, and CAPA Implementation & Tracking.
1. Minimum of Bachelor’s degree in life sciences or a related field with at least 5 years of cGXP work experience and capable of working in a fluid and fast-paced environment.
2. Extensive knowledge of FDA’s GMP, GTP and Donor Eligibility regulations and standards of the American Association of Tissue Banks.
3. Extensive cGXP Quality Management System knowledge with the ability to write SOP’s, business correspondence, and procedure manuals.
4. Highly competent in utilizing core quality systems such as Change & Document System Control, Deviation Management & Investigation, and CAPA Implementation & Tracking.
5. Familiarity with GXP manufacturing documentation for FDA regulated commercial manufacturing and QMS documentation for drugs/biologics
Additional Salary Information: Competitive salary for experience tissue banking or tissue product quality personnel based on experience.
Internal Number: 2002
About Skye Biologics
Skye Biologics develops and manufactures tissue products designed to assist the body in its natural ability to heal and remodel properly. These products are prepared and formulated to protect and augment degenerated or damaged tissues in surgical repairs and non-operative therapies.