Company

Meridian Medical Technologies, LLCSee more

addressAddressSaint Louis, MO
type Form of workNights
CategoryInformation Technology

Job description

Why Patients Need You
Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.
What You Will Achieve
You will be a team member who is relied to have a good understanding of procedures, techniques, tools, materials and equipment. Your decision making will help you prioritize workflows based on the available resources. You will follow standard procedures to complete tasks, some of which may vary in scope, sequence, complexity and timing. You will contribute to the team's success by sharing your previously acquired knowledge.
It is your hard work and focus that will make Meridian ready to achieve new milestones and help patients across the globe.
The main responsibilities of an Environmental Compliance Technician I involve performing environmental monitoring of the Aseptic Processing Area (APA). Individuals will also perform activities outside of the cleanroom including the examination of environmental monitoring samples for the recovery of microbial growth and the entry of data into a validated database. Sampling activities for this position includes viable surface and air monitoring, non-viable air monitoring and water sampling across the facility.
Individuals for this role should have strong leadership and interpersonal skills. Additionally, individuals should be respectful of others and be well respected by their peers. The individual should be comfortable working independently and be able to manage multiple activities occurring simultaneously. Lastly, individuals should have a basic understanding of microbiology, have a strong commitment to quality and be comfortable working in a laboratory environment.
Meridian operates under three shifts:
1st shift (0600-1430)
2nd shift (1400-2230)
3rd shift (2200-0630)
This will be a primarily be a second and third shift role and may require weekend support.
How You Will Achieve It
  1. Acquire proper knowledge and understanding of company and departmental policies pertaining to current Good Manufacturing Practices (cGMPs), Good Laboratory Practices (GLPs), safety, health and security.
  2. Perform various sampling activities, including viable surface/air samples, non-viable air samples and facility water samples, on a daily basis throughout the aseptic processing area.
  3. Required to actively demonstrate knowledge of practical laboratory skills, methodologies and procedures. Employees must be capable of using standard laboratory equipment and able to examine microbiological survey samples for the absence or presence of microbiological organisms.
  4. Must have mathematical reasoning skills and able to collect/ analyze data.
  5. Maintain accurate and concise records with attention to detail.
  6. Able to deal with frequent change, delays or unexpected events.
  7. When procedural deviations are noted, proper steps are to be taken to notify quality management. Ethical and integral work is required.
  8. Able to listen and obtain clarification from supervisory staff as required. Must be capable of writing clearly and informatively. Capable of evaluating and presenting numerical data effectively.
  9. Capable of completing tasks on time. Must be able to develop a plan or notify appropriate staff of when alternative plans are required.
  10. Must be able to interact with management and non-management employees. Treat others with respect and consideration regardless of their status, position and personal or cultural differences.
  11. Follow all safety and security procedures. Meet department safety objectives consistent with the job requirements.
  12. Become qualified on aseptic gowning and technique.
  13. Support quality functions involved in batch processing and GMP paperwork review.

Qualifications
Must-Have
  1. High School/GED and one year general work experience, and/or training; or equivalent combination of education and experience.
  2. Basic math and computer skills, such as data entry, along with a high level of attention to detail
  3. Understanding of equipment, instrumentation, and computer applications
  4. High productivity and the ability to multi-task coupled with a low error rate
  5. Ability to read, comprehend, and follow procedures
  6. Good oral, written and interpersonal communication skills within a diverse team setting

Nice-to-Have
  1. Associates degree or Bachelor's degree in biology, microbiology, or related field and previous experience preferred.
  2. Experience in a GMP environment

PHYSICAL/MENTAL REQUIREMENTS
While performing the duties of this job, the employee is exposed daily to work near moving mechanical parts. The noise level in the work environment is usually moderate but can be elevated in some areas of the Aseptic Processing Area (APA). The employee may be required to stand and walk several hours a day and lift and/or move up to 25 pounds. Specific vision abilities required by this job include ability to adjust focus. While performing the duties of this job, the employee must don a full body garb suit, hood, mask, goggles, and gloves. The employee will be required to remain in a full body garb suit, hood, mask, goggles, and gloves for several hours at time. Must have schedule flexibility, depending on the production schedule employees may be required to periodically work overtime, off-shifts (mornings, afternoons, nights or a combination of both), and/or holidays.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Position requires regular onsite attendance - this position cannot be performed on a remote or telecommute basis on a temporary, short or long term basis.
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. Note that these activities may not be time bound to core hours or presence at the site.
Must have the ability to work effectively under and manage to strict production, time and performance deadlines. Must be willing and able to work beyond the hours typically defined as a "regular" workday, including weekends and may or may not include holidays.
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.
Refer code: 7469082. Meridian Medical Technologies, LLC - The previous day - 2023-12-28 23:06

Meridian Medical Technologies, LLC

Saint Louis, MO
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