Job Information
Kedplasma Quality Assurance Manager in Farmington, New Mexico
Position : Quality Assurance Manager
Location : Farmington, NM
Your Job
Manages center Quality Assurance staff to include training, performance evaluation, career development, scheduling, compensation administration and progressive discipline as needed per company policies and procedures.
Coordinates the scheduling of the center Quality Assurance staff.
Guarantees data integrity by reviewing all aspects of the manufacturing process to ensure the completeness, and accuracy of records and documents within the quality systems.
Analyzes deviation tracking and trending data and implements appropriate CAPA to improve compliance and quality.
Plans and presents quality topics during regularly scheduled staff meetings and hosts a weekly QA staff meeting with Operations Management and Quality Assurance staff.
Manages on time resolution of error investigations and CAPA.
Drives center level CAPA initiatives generated from tracking and trending analysis.
Ensures final QA review and release for all product shipments and associated documents to ensure shipments meet regulatory customer specifications as needed.
Co-hosts customer, regulatory, and corporate audits of the center. In conjunction with regional and center management, completes all audit responses, including corrective/preventive action, and ensures that responses are submitted on time.
Partner with Training Coordinator to ensure that new hire and SOP training occurs and is effective.
The Requirements
Bachelor's degree in life science or related field preferred; or equivalent combination of education and experience.
Minimum four years' management experience in biologics, biotechnology or pharmaceutical industry with increasing quality responsibilities.
Demonstrated knowledge of FDA and EU regulations and standards.
Proficient in Microsoft Office software applications with intermediate Microsoft Excel proficiency.
Strong written and verbal communication skills.
Plasma industry experience preferred
Physical and Mental Working Conditions
Occasionally required to travel overnight.
Frequently performs work while walking or standing.
Frequently exposed to bloodborne pathogens and may be required to wear personal protective equipment.
Occasionally required to be in work environment > - 30o C and appropriate personal protective equipment.
May be required to work flexible work schedule, including weekends and holidays.
Occasionally required to lift, push and pull up to 25 pounds.
Required to communicate and interact with employees and donors.
The purpose of this position is to manage quality operations of a plasma collection center to ensure operations are in compliance with quality regulations. The Center Quality Manager has the authority to stop production and/or plasma shipment release based on their professional judgment and discretion. Operates within the scope of EU Guidance on Good Manufacturing Practice and FDA cGMP 21CFR.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status.