Job Description
Job Description
Classification: Hourly/Non-Exempt
Reports to: Training Manager
PURPOSE
The Training Coordinator performs under the direction of the Training Manager. This position is responsible for the effective training and documentation at donor centers. Ensure all training is properly completed and documentation of all training activities is in compliance with Regulatory guidelines and approved ABO Plasma Training Program.
General Requirements – Adhere to all Standard Operating Procedures, Current Good Manufacturing Practices and Company Policies. Ensure facility is in compliance with all applicable state, federal, consignees and ABO designated regulations. Ensure donor suitability, product integrity, and continued good health of donors through the center’s compliance with Food and Drug Administration (FDA) regulations, state regulations, the Standard Operating Procedure Manual guidelines of the Company and any other applicable regulatory standards.
ESSENTIAL RESPONSIBILITIES & DUTIES
- Ensure center adherence to ABO Plasma Training Program standards and annual training requirements.
- Coordinate New Hire Onboarding Program with HR and Center Management.
- Works with HR and Center Manager during the background processing of candidates to help gather missing data, etc. Ensure with HR that candidate has all that is required to start work at ABO.
- Sends New Hire Orientation email to candidates prior to their start date. Conducts the New Hire Orientation for new employees.
- Notifies HR that the candidates have arrived to start work with ABO.
- Oversee and coordinate the center’s certification schedule; initial, annual, CPR.
- Monitor and evaluate training effectiveness for assigned center.
- Develop and coordinate training schedules for all new hires (orientation through certification).
- Performs retraining of staff members
- Assists with performing 6-month and Annual assessment for center personnel.
- Work in conjunction with Management and Quality to identify and implement corrective measures to eliminate regulatory deficiencies in training.
- Assists with development and improvement of Company’s SOP and Training Program.
- Coordinates and/or perform employee training of the Company’s SOP and other regulations.
- Coordinates and conducts annual OSHA, CGMP, and unplanned variation training.
- Coordinates and performs Annual CLIA assessments for required employees according to the Company’s SOP.
- Reports to Center Management and Quality Assurance any errors/incidents/events that may affect the safety, purity, identity, or quality of blood products.
- Complete required performance observations to assess employee performance; monthly performance observations completed for certified staff (including DTs), weekly observations completed for Designated Trainers assigned to new hires.
- Ensure training and documentation of new SOP implementations and all in-services.
- Routinely evaluate DT competency, documentation, knowledge-transfer skills and customer service (internal/external).
- Collect and evaluate data to identify training gaps.
- Work with center management team to implement operational changes to enhance center operational effectiveness
- Report all training matters to Center Manager and Training Manager on a weekly basis (or as needed).
- Travel to other ABO centers as needed for training and support.
- Maintain thorough familiarity and compliance with State and Federal regulations, Standard Operating Procedures Manual, Training Manual, OSHA, cGMP, PPTA, CLIA, AABB, GCC requirements and internal company procedures.
- Adhere to all company policies, procedures and safety rules as stated in the Employee Handbook and as otherwise posted or communicated.
- Any other duties as assigned.
REQUIREMENTS
- Bachelor’s degree (B.A.) with 1-2 years relevant work experience or 3-5 years relevant work experience required.
- Minimum of 2 years management experience in a regulatory industry required
- Plasma Industry experience preferred
- 1-2 years minimum Supervisory experience required
- Current CPR Card
- Certified in Reception area, Donor Floor area and Plasma Processing area within 6 months of starting Training Specialist job.
- Must demonstrate excellent interpersonal, verbal and written communication skills appropriate for all interactions with employees.
- Must be flexible to work in an ever changing and fast-paced work environment.
- Computer skills including proficient in Microsoft Office
- Demonstrate spreadsheet and database computer skills
- Travel as required
PHYSICAL DEMANDS
Performing the responsibilities of the job requires regular use of hands to finger, handle, or feel objects, tools or controls, and to reach with the hands and arms. Frequently required to stand, walk, climb, or balance; and to stoop, kneel or crouch. May be required to walk and stand for entire work shifts. Ability to read and type while sitting in front of a computer for up to 4-hours at a time. Physically able to use and operate equipment used in assessing donor suitability as well as equipment used to harvest plasma. Manual dexterity to perform all phases of plasmapheresis. Ability to lift tug and pull up to 50 pounds.
WORK ENVIRONMENT
This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. May be exposed to bloodborne pathogens and other conditions common to a donor center. Personal protective equipment required such as eyewear, lab coats, and gloves. May work in a walk-in freezer for short intervals of time (-20C or colder).