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Aseptic Qualification Training Specialist

Meridian Medical Technologies, LLC
Saint Louis, MO
  • Posted: over a month ago
  • Full-Time
Job Description

ROLE SUMMARY

Recognized as a subject matter expert with specialized knowledge and skills in aseptic procedures, techniques, and equipment. Responsible for delivery and documentation of structured on-the-job training qualifications for production operators. This role works effectively as a member of the SPM Training Team as well as directly with Business Area Manufacturing supervision, SMEs, and Filling Operators to support aseptic training initiatives.

ROLE RESPONSIBILITIES

  • Maintains qualification status and acts as subject matter expert for aseptic procedures, techniques, and equipment. Provides feedback when problems arise with processes and equipment based on experience.
  • Responsible for on the floor training of new production technicians including demonstration of tasks, guided practice with Trainees, and final proficiency assessment.
  • Monitors all aspects of the trainee's progression against the training schedule. Provides Trainees with feedback against established learning objectives and performance standards.
  • Maintains operator OJT documentation during the training process. Signs OJT documentation as Qualified Trainer.
  • Performs requalification of SPM operators to ensure proficiency and operational standards are maintained.
  • Assists department supervision to review shift schedules and confirm training status of Operators. Immediately escalates training related issues as required.
  • Performs all training activities ensuring quality, compliance, safety, and production standards are met.
  • Participates on the site Technical Training team and works collaboratively with site leadership.
  • Contributes to continuous improvement of the operator training process to address gaps and implement best practice.
  • Assists with MIR/CAPA training as required.
  • Perform other related duties as assigned or required

BASIC QUALIFICATIONS
- Minimum 3 years aseptic manufacturing or training experience, AA Required, BA Preferred
- Excellent verbal and written communication skills
- Ability to effectively communicate and demonstrate/present to an individual or a group.
- Proficient at the use of Microsoft Office Suite.
- Must, be conscientious, dependable, and possess leadership and critical thinking skills.
- Must be capable of making sound decision while being able to assess situations to determine if management involvement is needed.
- Candidate must possess the ability to work effectively with a team, collaborate and communicate with all levels of union members and management team members, and work cross-functionally within a team environment.

Physical/Mental Requirements
While performing the duties of this job, the employee is regularly required to sit, stand, walk and talk or hear; reach with hands and arms; stoop kneel, crouch; must occasionally lift and/or move up to 25 pounds.
Specific vision abilities required by this job include ability to identify and distinguish colors and to adjust to focus.
Use of eye protection, gloves, and PPE is required.
The employee must be able to work areas of the facility that requires all body parts to be completely covered (gowned) for substantial periods of time.

Non-Standard Work Schedule, Travel or Environment Requirements

This position requires regular onsite attendance. This position cannot be performed on a remote or telecommute basis, on a temporary, short or long-term basis.

Each shift representation needs to have the ability to work a flexible schedule as needed. Must have the ability to simultaneously multi-task across multiple capabilities and functions and handle multiple competing priorities and requirements, including performing site and functional responsibilities, responding to frequent e-mail and phone communications and attending multiple meetings and conference calls. These activities may not be time bound to core hours or presence at the site.

Meridian Medical Technologies (MMT) is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. MMT also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.

MMT requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, MMT will consider requests for Reasonable Accommodations.

Meridian Medical Technologies, LLC

Address

Saint Louis, MO
63146 USA

Industry

Education

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