About Alcami

Alcami is a world-class contract development and manufacturing organization (CDMO). We are a team of dynamic individuals committed to developing life-saving drugs around the world. A mindset of innovation, accountability and customer focus inspires us to be the most efficient, safe and reliable choice for our customers and the patients they serve. In return, we offer challenging careers, accelerated professional growth and the opportunity to be part of something different.

Position Summary

The Senior Quality Specialist is accountable for driving results in a fast-paced environment by effectively performing activities of substantial variety and complexity to ensure quality and compliance with applicable regulatory requirements and is proficient in all document and protocol approvals applicable to the respective processes executed at the respective lab or manufacturing facility. These activities include reviewing documents and data, conducting audits and inspections, consulting on quality and compliance issues, maintaining quality databases and performing trend analysis where needed, and performing quality and compliance training as needed. The position serves as quality host for client and regulatory agency audits and inspections. The position develops SOPs or other quality documents as needed. The position provides guidance and mentoring for other Quality employees. Serves as a back-up to site Quality Management for technical Quality decision making. The position requires superior leadership behaviors of the Alcami core competencies and non-negotiables, as well as expertise in functional competencies included in this position profile.

Essential Functions

Education and Experience

Alcami Non-Negotiables

Alcami Core Leadership Competencies

Functional Competencies

Decision Making and Supervision Required

Travel Requirements

Physical Demands and Work Environment

The physical demands and work environment characteristics 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 may be required to use hands to finger, handle, or feel and to reach with hands and arms. The employee is required to talk and hear. The employee is frequently required to stand, walk and sit. The employee may be occasionally required to climb or balance. The employee may be required to regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, and peripheral vision. While performing the duties of this job, the employee may be occasionally exposed to moving mechanical parts, high precarious places and vibration. The noise level in the work environment is usually quiet. The employee may be required to gain access to lab, or manufacturing areas for inspections or work discussions. The noise level in these additional work areas may be louder. The employee is required to wear the appropriate personal protective equipment to perform the job duties. Such personal protective equipment may include but is not limited to: safety eyewear, various types of respirators/breathing apparatus, lab coats, gloves, etc.

Other Duties

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.