BMR Facility Specialist
BMR Facility Specialist
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Job Description
Overview:
Job Description Summary:
Job Description:
Essential Functions:
- Performs routine cleanroom facility cleaning changeover environmental monitoring and Shutdown duties and manages inventory and supply areas. Adheres to gowning requirements and hygiene.
- Practices proper cleaning methods of bio-contamination control in conjunction with cleaning procedures. Maintains equipment and supplies in a clean orderly fashion and in good working condition.
- Reviews GxP documentation related to cleaning and disinfection for completion and accuracy. Files documentation for timely retrieval.
- Participates in cross-functional quality event investigations related to cleaning and disinfection as necessary.
- Maintains compliance with applicable regulatory requirements for products and cleaning documentation. Meets or exceeds regulatory standards of quality as evidenced by quality assurance inspections.
- Operates within the Quality Management System applicable to the manufacture of phase appropriate material in the manufacturing facility.
- Provides documentation of all activities performed. Makes decisions based on established procedures and performs in accordance with established policies procedures and techniques.
Education Requirement:
- High School Diploma/Equivalent required.
- Background in life sciences biotechnology or gene therapy industries preferred.
Skills:
- Understanding of GxP is preferred.
- Must be computer literate in Microsoft Office (PowerPoint Excel Word).
- Excellent communication organization and project management skills with the ability to manage multiple projects efficiently and adjust as priorities change.
- Ability to work independently as well as collaboratively in a diverse and collaborative team environment. Utilizes clear communication to deliver high productivity and contribute to the success of team and goals.
- Must be able to exercise discretion judgment and personal responsibility while demonstrating a high level of integrity positive attitude and attention to detail.
- Comprehends basic concepts of room classifications air flow biosafety levels etc. in order to operate using appropriate methods and routes.
- Demonstrates knowledge of appropriate chemical use to meet department standards (know chemical its proper use and preparation appropriate labeling and storage requirements etc.)
Experience:
- Experience in highly regulated field preferred. Requires training or working knowledge related to the tasks performed
- Must possess prior experience handling confidential information and the ability to maintain confidentiality.
Physical Requirements:
OCCASIONALLY: Bend/twist Biohazard waste Blood and/or Bodily Fluids Chemicals/Medications Climb stairs/ladder Flexing/extending of neck Lifting / Carrying: 0-10 lbs Lifting / Carrying: 11-20 lbs Lifting / Carrying: 21-40 lbs Lifting / Carrying: 41-60 lbs Pushing / Pulling: 0-25 lbs Pushing / Pulling: 100 lbs or greater with assistance Pushing / Pulling: 26-40 lbs Pushing / Pulling: 41-60 lbs Pushing / Pulling: 61-100 lbs Reaching above shoulder Squat/kneel
FREQUENTLY: Computer skills Decision Making Hand use: grasping gripping turning Interpreting Data Problem solving Repetitive hand/arm use Sitting Standing Walking
CONTINUOUSLY: Audible speech Color vision Depth perception Hearing acuity Peripheral vision Seeing Far/near
The above list of duties is intended to describe the general nature and level of work performed by individuals assigned to this classification. It is not to be construed as an exhaustive list of duties performed by the individuals so classified nor is it intended to limit or modify the right of any supervisor to assign direct and control the work of employees under their supervision. EOE M/F/Disability/Vet
Required Experience:
Unclear Seniority
Employment Type
Full-Time
