Work at ImmunoTek

Job Functions

1. Promote customer satisfaction through appropriate interaction and responsiveness to customer needs.
2. Monitor and evaluate operation and provide feedback to supervisor.
3. Actively transition to areas of need to promote operational efficiencies.
4. Determine donor suitability through initial check of accumulated data.
5. Create donor record and enter accurately enter donor information
6. Perform pre-donation medical screening and/or assessment in accordance with established guidelines.
7. Learn the requirements and processes for Refractometer quality control, preventive maintenance, and troubleshooting.

• Maintain all permanent files in an organized and efficient manner.

9. Monitor and evaluate production activities and provide feedback to supervisor.
10. Proper setup of all equipment and disposable supplies.
11. Constant monitoring of donors and equipment operation to ensure health of donor, identify potential adverse reactions, and promote product quality.
12. Disconnect and dispose of all contaminated disposable equipment.
13. Obtain all necessary samples accurately and efficiently
14. Accurate and thorough completion of all sampling and shipping documents.
15. Freeze units for final packing.
16. Accurate and thorough documentation of necessary records.
17. Attend all required training sessions, staff meetings, etc.
18. Maintain thorough familiarity with State and Federal regulations, Standard Operating Procedures manual, European regulations, OSHA, CLIA, cGMP, as well as all internal company procedures.
19. Maintain equipment and work area in a clean and organized manner, and report all equipment in need of repair.
20. Maintain supplies necessary to perform all job duties.
21. Report all unsafe situations or conditions to supervisor.
22. Responsible for maintaining a consistent, regular attendance record.
23. May be required to work weekends, evenings and some holidays.

Additional Duties and Responsibilities

1. Performs other duties as assigned, including but not limited to, cleaning of all areas of the Center, receiving and shipping of products and materials.
2. May be assigned to train or work with new employees.
3. May be assigned to assist in other areas as needed.

Qualification Requirements

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

1. Education and/or Experience High School diploma or GED required. State license, where required
2. Special Qualifications Strong organizational and interpersonal skills required. Must have legible handwriting. Must be able to use PC.
3. Language Skills Ability to read and interpret documents such as safety rules, operating and maintenance instruction, and procedure and technical manuals. Ability to write routine reports and correspondence. Ability to speak effectively before groups of customers or employees of organization.
4. Mathematical Skills Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
5. Reasoning Ability Ability to define problems, collects data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

Physical Demands

The physical demands 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.

1. While performing the duties of this job, the employee is regularly required to use hands to finger, handle, or feel objects, tools, or controls; reach with hands and arms; and talk or hear. The employee frequently is required to stand; walk, climb or balance; and stoop, kneel, or crouch.
2. Manual dexterity to perform all phases of donor screening. Ability to stand for extended periods of time – up to four (4) hours at a time. Ability to lift, tug, pull up to fifty (50) pounds.

Job Functions

1. Promote customer satisfaction through appropriate interaction and responsiveness to customer needs.
2. Monitor and evaluate operation and provide feedback to supervisor.
3. Actively transition to areas of need to promote operational efficiencies.
4. Determine donor suitability through initial check of accumulated data.
5. Create donor record and enter accurately enter donor information
6. Perform pre-donation medical screening and/or assessment in accordance with established guidelines.
7. Learn the requirements and processes for Refractometer quality control, preventive maintenance, and troubleshooting.
8. Maintain all permanent files in an organized and efficient manner.
9. Monitor and evaluate production activities and provide feedback to supervisor.
10. Proper setup of all equipment and disposable supplies.
11. Constant monitoring of donors and equipment operation to ensure health of donor, identify potential adverse reactions, and promote product quality.
12. Disconnect and dispose of all contaminated disposable equipment.
13. Obtain all necessary samples accurately and efficiently
14. Accurate and thorough completion of all sampling and shipping documents.
15. Freeze units for final packing.
16. Accurate and thorough documentation of necessary records.
17. Attend all required training sessions, staff meetings, etc.
18. Maintain thorough familiarity with State and Federal regulations, Standard Operating Procedures manual, European regulations, OSHA, CLIA, cGMP, as well as all internal company procedures.
19. Maintain equipment and work area in a clean and organized manner, and report all equipment in need of repair.
20. Maintain supplies necessary to perform all job duties.
21. Report all unsafe situations or conditions to supervisor.
22. Responsible for maintaining a consistent, regular attendance record.
23. May be required to work weekends, evenings and some holidays.

Additional Duties and Responsibilities

1. Performs other duties as assigned, including but not limited to, cleaning of all areas of the Center, receiving and shipping of products and materials.
2. May be assigned to train or work with new employees.
3. May be assigned to assist in other areas as needed.

Qualification Requirements

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

1. Education and/or Experience
   High School diploma or GED required. Knowledge and technique of blood collection/plasma collection.
2. Special Qualifications
   Strong organizational and interpersonal skills required. Must have legible handwriting. Must be able to use PC.
3. Language Skills
   Ability to read and interpret documents such as safety rules, operating and maintenance instruction, and procedure and technical manuals. Ability to write routine reports and correspondence. Ability to speak effectively before groups of customers or employees of organization.
4. Mathematical Skills
   Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
5. Reasoning Ability
   Ability to define problems, collects data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

Physical Demands

The physical demands 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.

1. While performing the duties of this job, the employee is regularly required to use hands to finger, handle, or feel objects, tools, or controls; reach with hands and arms; and talk or hear. The employee frequently is required to stand; walk, climb or balance; and stoop, kneel, or crouch.
2. Manual dexterity to perform all phases of donor screening. Ability to stand for extended periods of time – up to four (4) hours at a time. Ability to lift, tug, pull up to fifty (50) pounds.

Job Functions

1. Assist in creating appropriate organizational environment and value system which stimulates the morale and productivity of the work force and its leadership.
2. Assist in providing strategic direction, planning and customer focus.
3. Establish and maintain the ability to perform any/all tasks within the plasma center; fulfill role of production employee when the need arises.
4. Monitor and evaluate operations, to include budget, and provide feedback to the Center Director.
   Assist in ensuring collected products and samples are stored and maintained in accordance with established regulations, customer requirements and SOP’s.
5. Maintain and monitor freezer performance including after hours on call responsibilities and vendor relationships needed for emergency freezer repair services and product temperature maintenance e.g. dry ice supplier.
6. Maintain thorough familiarity with Federal and State regulations, FDA approved Standard Operating Procedure manual, European regulations, OSHA, CLIA, and cGMP.
7. Supervise donor screening, plasma collection, and plasma processing and all manufacturing records to maintain the highest production standards in accordance with Federal and State regulations, FDA approved Standard Operating procedure manual, European regulations, OSHA, CLIA, and cGMP.
8. Attend all required training sessions, staff meetings, etc.
9. Ensure that accurate and thorough documentation of necessary records is performed.
10. Provide quality leadership and follow through of company objectives during absence of the Center Director. Work in a “partnership” with the Quality Supervisor(s) to promote productive interactions between Operations and Quality personnel.
11. Assure facility is maintained in a neat and clean condition and all equipment is kept in good working order.
12. Submit timely and accurate reports as necessary.
13. Assist in control of center donor funds.
14. Minimize center liability through constant risk management review.
15. Assist in training new employees and retraining current employees; maintain Trainer Certification.
16. Signed Statement of Responsibility and Curriculum Vitae on file at the center and authorized official’s office.
17. Assist Center Director in any task necessary in pursuit of company objectives.
18. Responsible for maintaining a consistent, regular attendance record.
19. May be required to work weekends, evenings, unusual hours during the night and some holidays.

Additional Duties and Responsibilities

1. Performs other duties as assigned, including but not limited to, cleaning of all areas of the Center, receiving and shipping of products and materials.
2. May be assigned to train or work with new employees.
3. May be assigned to assist in other areas as needed.

Qualification Requirements

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

1. Education and/or Experience
   High School diploma or GED required. Two (2) year experience in plasma center, including one year experience in supervisory position or Associate degree in Science or Management with no supervisory experience. General knowledge of all operating procedures of the center.
2. Special Qualifications
   Strong organizational and interpersonal skills required. Must have legible handwriting. Must be able to use PC.
3. Language Skills
   Ability to read and interpret documents such as safety rules, operating and maintenance instruction, and procedure and technical manuals. Ability to write routine reports and correspondence. Ability to speak effectively before groups of customers or employees of organization.
4. Mathematical Skills
   Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
5. Reasoning Ability
   Ability to define problems, collects data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

Physical Demands

The physical demands 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.

1. While performing the duties of this job, the employee is regularly required to use hands to finger, handle, or feel objects, tools, or controls; reach with hands and arms; and talk or hear. The employee frequently is required to stand; walk, climb or balance; and stoop, kneel, or crouch.
2. Manual dexterity to perform all phases of donor screening. Ability to stand for extended periods of time – up to four (4) hours at a time. Ability to lift, tug, pull up to fifty (50) pounds.

Job Functions

1. Promote customer satisfaction through appropriate interaction and responsiveness to customer needs.
2. Monitor and evaluate operation and provide feedback to supervisor.
3. Determined donor suitability through initial check of accumulated data.
4. Perform pre-donation medical screening and/or assessment in accordance with established guidelines.
5. Perform Donor Medical History screening and/or assessment in accordance with established guidelines.
6. Maintain all permanent files in an organized and efficient manner.
7. Accurate and thorough documentation of necessary records.
8. Attend all required training sessions, staff meetings, etc.
9. Maintain thorough familiarity with State and Federal regulations, Standard Operating Procedures manual, European regulations, OSHA, CLIA, cGMP, as well as all internal company procedures.
10. Maintain equipment and work area in a clean and organized manner, and report all equipment in need of repair.
11. Operate, maintain, troubleshoot, and perform calibrations on testing and donor screening equipment.
12. Maintain supplies necessary to perform all job duties.
13. Report all unsafe situations or conditions to supervisor.
14. Responsible for maintaining a consistent, regular attendance record.

Additional Duties and Responsibilities

1. Performs other duties as assigned, including but not limited to, cleaning of all areas of the Center, receiving and shipping of products and materials.
2. May be assigned to train or work with new employees.
3. May be assigned to assist in other areas as needed.

Qualification Requirements

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

1. Education and/or Experience
   High School diploma or GED required.
   State license, where required
2. Special Qualifications
   Strong organizational and interpersonal skills required. Must have legible handwriting. Must be able to use PC.
3. Language Skills
   Ability to read and interpret documents such as safety rules, operating and maintenance instruction, and procedure and technical manuals. Ability to write routine reports and correspondence. Ability to speak effectively before groups of customers or employees of organization.
4. Mathematical Skills
   Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
5. Reasoning Ability
   Ability to define problems, collects data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

Physical Demands

The physical demands 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.

1. While performing the duties of this job, the employee is regularly required to use hands to finger, handle, or feel objects, tools, or controls; reach with hands and arms; and talk or hear. The employee frequently is required to stand; walk, climb or balance; and stoop, kneel, or crouch.
2. Manual dexterity to perform all phases of donor screening. Ability to stand for extended periods of time – up to four (4) hours at a time. Ability to lift, tug, pull up to fifty (50) pounds.

POSITION PURPOSE:

The Quality Training Manager delivers, oversees, monitors training programs, and develops training materials for area specific training, soft skills training, and other topics as needed. The Quality Training Manager is responsible for ensuring training compliance with internal Standard Operating Procedures and external customer and regulatory body requirements. S/he will ensure that the training completed encompasses the quality and manufacturing requirements from FDA and EU regulations in addition to the ImmunoTek Quality Plan to facilitate Donor Center and business compliance.

ESSENTIAL JOB FUNCTIONS:

1. Conducts introductory on-boarding training for employees, as needed.
2. Develops program to train employees prior to new center opening. Oversees Quality training for new center openings at the training center, as needed.
3. Conducts training follow-up visits (post center-opening) to ensure training activities are in compliance with all ImmunoTek Training policies.
4. Identifies areas where training materials are lacking and initiates revisions to material as needed. Ability to initiate/revise materials without approval based on employee’s identification of need for revision.
5. Creates / revises training material for SOP revisions within area of expertise.
6. Creates / revises employee exams specific to areas of expertise.
7. Assists Director of Training in the development and management of system-wide CAPA Plan related to training issues.
8. Conducts general training, as directed.
   1. GMP / FDA / EU
   2. DMS
   3. MasterControl
   4. Safety
   5. Area specific
9. Conducts Quality training, as directed.
10. Formats / Reviews training material contents for consistency.
11. Provides direct supervision for all pre-center opening Quality trainees including. Works with Human Resources department to resolve any issues that arise during training.
12. May be required to work evenings and weekends.
13. Assist with special training projects and initiatives as needed.

Additional Duties and Responsibilities:

• Maintains current knowledge of FDA, EU, and applicable state regulations in addition to customer specifications.
• Special projects as assigned

Supervisory Responsibilities:

Has direct supervisory responsibilities for pre-open center Quality trainees, as assigned by Director of Training.  Serves in advisory role for post-open centers to center management to assure center training and cGMP regulatory compliance relative to FDA and EU regulations via process improvement initiatives.

QUALIFICATION REQUIREMENTS:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Ability to teach others concepts, tasks, and processes.
• Ability to create training material specific to employee responsibility / scope / education level.
• Ability to assist in the design process for: interactive learning courses, classroom workshops, job aids, and other training materials according to need.
• Ability to travel up to 75% of time.
• Excellent written and oral communication skills

            JOB SPECIFICATIONS:

1. 1 (1) year experience and/or significant training and expertise in preparing and delivering informational and instructional programs for adults and effective uses of technological education tools and audio/visual equipment.
2. Knowledge of a variety of software programs, including Microsoft Office and training resources and equipment.
3. Ability to work on multiple tasks concurrently and adhere to strict deadlines; attention to detail; demonstrated research and analytical skills.
4. Excellent human relations, interpersonal, written and verbal communication skills required.
5. Ability to create clear and effective learning courses, job aids, and other needed documentation.
6. Ability to organize projects, priorities, and manage time effectively

PHYSICAL DEMANDS:

The physical demands 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.

1. Ability to view video display terminal images for extended periods of time
2. Ability to operate a computer keyboard and telephone
3. Ability to sit for extended periods of time
4. Ability to lift, tug, pull up to forty (40) pounds.

WORK ENVIRONMENT:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The noise level in the work environment is usually moderate.  May be exposed to short periods of time to freezing temperatures. May have occupational exposure to bloodborne pathogens.