Position Overview

The Manufacturing Logistics QMS Senior Associate is responsible for working independently and with others to perform Quality Management System activities pertaining to the Manufacturing Department. This individual serves as an embedded quality assurance representative within the Manufacturing Department.

Essential Duties and Responsibilities

• Author and execute CAPA plans, deviations, and change controls.

• Lead investigations for deviations from procedures (quality events).

• Review batch-related documentation and ensure resolution of issues to release product.

• Assist in implementing improvement ideas.

• Additional responsibilities as assigned.

  Qualifications

• BS in life sciences, engineering, or other relevant discipline with 1 to 4 years of relevant experience.

• Strong oral, written and interpersonal communication skills

• Previous experience in pharmaceutical, biotech, or biologics cGMP regulated manufacturing environment is preferred but not required.

• Experience conducting compliance investigations is preferred.

  Other Skills and Abilities

• Strict attention to detail and safety.

• Proficiency in MS word, Excel, Power Point, Microsoft Office 365, and other applications

• Must possess effective interpersonal, verbal, and writing skills, patience, professionalism, and the ability to effectively interact and communicate with internal staff and management. 

• Ability to thrive in a fast-paced, patient-focused manufacturing environment with minimal direction and able to adjust workload based on changing priorities.

  Physical Demands

  The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to bending, stooping, moving equipment, and stretching. A normal range of hearing and vision correctable to 20/20 is required. Occasional lifting up to 30 pounds is required.

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