Job Title: Compliance Associate I - Lansing Area of Interest: Blood Services
Quality Assurance
Job Description:
Collections Compliance Support Associate I - Lansing, Michigan
Full Time - Exempt
Responsible for regulatory functions at multiple operations including, but not limited to, machine oversight, product quality control, departmental audits and document control oversight. Assist with change management as assigned. Department liaison to field operations for regulatory processes.
Manage distribution and tracking of required communications to all collection staff. Provides retraining of staff.
Perform all duties and responsibilities in compliance with standard operating procedures, Safety Quality Identity Potency Purity (SQUIPP), regulations outlined in the Code of Federal Regulations (CFR), Occupational Safety and Health Administration (OSHA) and other applicable Federal, state and local regulations.
Responsibilities
1. May processes department related problems through the problem management system. Ensures the reports are accurate and complete and written in a clear and concise manner. Attend root case meetings as assigned.
2. Assist with management of suspect products.
3. Processes any combination of reports which may include: customer complaints, material review board process, supply and equipment problem deficiency reports.
4. May participate in internal and external inspections/evaluations as necessary.
5. Liaison between operational department and regional management as it pertains to compliance. Interacts with staff routinely and brings operational issues to appropriate Regional management staff's attention.
6. May assist with education activities for new and incumbent staff and determine staff competency. Ensure documentation of training and regulatory communications are accurate and timely.
7. Perform preventative maintenance, corrective maintenance and quality control checks in accordance with written procedures.
8. Plan for and ensure that adequate equipment and supplies are available at all mobile operations.
9. Maybe responsible for ensure the required supplies & kits are loaded on the trucks/vans that supply the blood mobiles.
10. Performs other duties as assigned.
The above statements are intended to describe the general nature and level of work being performed. They are not intended to be an exhaustive list of all responsibilities and duties required of staff so classified.
Scope
Support collection department regulatory functions and related process improvement initiatives.
Operates under minimal guidance. Plans own work and set priorities within guidelines. Actions and decisions based upon precedent, organizational need and good judgment.
Qualifications
Bachelor's degree or equivalent combination of education and related experience is required. Minimum one year related experience required. Excellent organizational skills, the ability to handle multiple priorities, effectively, analyze problems and recommend appropriate solutions and ability to assimilate information quickly. Excellent written and oral communication skills and ability to deal with all levels of staff, vendors, physicians, volunteers or donors.
Competencies
The duties and responsibilities mentioned in the job description are representative of the essential functions of the position. The performance management system incorporates competencies which are identified, discussed and evaluated in order to meet operational milestones and which are tied to job families and titles. Three types of competencies have been identified; Technical Competencies are job specific skills and methods, Core Competencies are the abilities and behaviors expected of all Biomedical Services employees, Leadership Competencies are specific abilities and behaviors required of those performing formal management roles or other leadership roles (i.e. Project Leaders). Management and staff should contact Human Resources for further details on the appropriate competencies for a specific position.
Essential Functions/Physical Requirements
The duties above indicate the essential functions of the position. Operational flexibility is required to meet sudden and unpredictable needs. May be required to travel.
Exposure levels are based on the essential functions as stated in this position description; however, in some instances, variances may occur due to the applicable nature of this position within a particular work site. Therefore the work site may determine the exposure level to be greater than or less than the below stated level.
This position is in exposure category II in view of the fact that the incumbent occasionally, on an unplanned basis, is required to work under conditions whe... For full info follow application link.
As an Affirmative Action/Equal Opportunity Employer, well-qualified women, minorities, veterans and persons with disabilities are encouraged to apply.