BMR Facility Specialist

 

 

 

Collaborates to perform critical cleanroom contamination control strategies such as routine cleaning and disinfection, documentation review, and projects and tasks. Supports production efforts by following appropriate practices, Standard Operating Procedures (SOPs), and Job Aides.

 

 

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"