The purpose of this position, under Center Manager/Assistant Manager supervision, is to gain the experience and knowledge required to perform the day-to-day operations of all aspects of the plasma collection center. Operates within the scope of EU Guidance on Good Manufacturing Practice and FDA cGMP 21CFR.
- Trains in all areas of the plasma collection center to gain functional knowledge of processes and procedures.
- Reviews the performance of all center activities and ensure all are in compliance with the SOP and regulatory guidelines.
- Learns to accurately review test results and ensures proper action is taken for abnormal and reactive results including removal from inventory, computer entry, completion of Look Back Notification/BPDR, and donor counseling.
- Maintains compliance with EU, FDA, state, local and company-specific regulations related to employee and donor safety, and unit suitability.
- Gains thorough knowledge of plasma shipments and sample submissions, ensuring accuracy and performance in accordance with shipping schedules.
- Learns and ensures that all required temperature ranges are maintained and intervene when required to ensure suitability of product as required, including responding to freezer alarms.
- Maintains a professional and courteous relationship with donors and works to maximize donor retention and production growth.
- Develops skill sets for forecasting and attaining production and cost goals while ensuring compliance with company, local and federal regulations.
- Maintains accurate inventory of supplies and goods.
- Performs self-audits of center logs and procedures and work closely with QA and Training staff to effectively resolve any issues noted.
- Completes and monitors payroll records to ensure employee hours are used efficiently.
- Monitors all marketing and advertising activities and works with corporate marketing department to maximize success of advertising and marketing campaigns.
- Develop skill sets needed to manage departmental employees including training, performance evaluation, career development, compensation administration and progressive discipline as needed according to HR policies and procedures.
- Responds to and resolves complex equipment alarms or donor issues related to processing donors.
- Demonstrates good decision-making ability, effective reinforcement, supervisory responsibility, and customer service.
- Bachelor’s degree in Business Administration, Life Sciences or related field, or two years’ experience in a regulated environment in lieu of education.
- Minimum of one-year management and/or experience preferably in a regulated environment; or equivalent combination of education and experience preferred.
- Proficient in Microsoft Office applications.
- Must be able to relocate upon successfully achieving training certification.
- 401(k) with company match
- Make a difference – we save lives!