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Manufacturing GMP Cleaner

2 months ago

Fremont, United States eTeam Full time
Job Title: Manufacturing GMP Cleaner
Location: Fremont, CA
Duration: 6 Months

Shift Timings: Tues-Sat, 2:00PM-10:30PM

Duties
  • Performs and coordinates GMP cleaning and Sanitization of process areas on the manufacturing floor as assigned related to the manufacturing of bulk drug substance in a multi-product facility.
  • Responsible for cleaning, sanitization of small parts and hoses used in the manufacturing process.
  • Performs duties under limited supervision and according to standard operating and manufacturing procedures.
  • Documents work according to cGMP and cGDP.
  • Adheres to established regulations and follows cGMP established by site.
  • Reports abnormalities and deviations in a timely and accurate manner.
  • Adheres to safety standards and identifies unsafe situations / habits and escalates appropriately.
  • Maintains production areas according to predefined standards (5s).
  • Prepares cleaning solution applicate to the area.
  • Cleans specified rooms on the manufacturing floor using approved cleaning solution, wearing appropriate PPE including respirator maybe required.
  • Perform other duties as assigned such as, trash removal, floor to ceiling cleaning, tidying up areas (5S), and potentially cleaning of small parts and equipment, performing real time documentation of cleaning in each area.
  • Responsible to be current with online training and qualifications.
  • Working in a highly regulated environment following all applicable client's Fremont SOPs, OCPs and BGSs for cGMP, EHS and Compliance policies.
  • Required to work according to given schedules in a 24/7 shift structure and flexibility to adapt working schedule upon prior given notice.
  • GMP room cleaning and trash removal.

Skills:
  • 1 or more years of experience in cGMP regulated industry desired.
  • Physically demanding, requires great attention to details and thorough accurate ability to document activities real time.
  • Moderate to high - strong focus on execution of tasks with moderate technical complexity.
  • Performs moderate proceduralized tasks.
  • Identifies process anomalies and areas for improvement for operations.
  • Strong working knowledge of fundamental manufacturing concepts is required.
  • Moderate technical knowledge of biologics operations is preferred.
  • Ability to concentrate on detail-oriented work in a moderate technical setup with a Quality and Right the first-time mindset.
  • Strong written and verbal communication skills.
  • Ability to work with computer-based systems and ideally experience with process.
  • Must become familiar with cleaning chemical components and safety requirements.

PHYSICAL DEMANDS:
Wear proper PPE that may include respirator to protect from cleaning agents, safety shoes, gloves.
Must be able to obtain full medical respiratory clearance and successfully complete respirator fit test.
Ability to perform repetitive motions and may require bending and reaching overhead, ability to lift up to 40 lbs.

NOTE: WORKERS MUST SUCCESSFULLY COMPLETE A RESPIRATOR FIT TEST AS WEARING A RESPIRATOR WILL BE REQUIRED FOR THIS POSITION. SUCCESSFUL FITTING OF RESPIRATOR MUST BE COMPLETED PRIOR TO START OF ASSIGNMENT.

Education:
  • High School Degree, desired 1-2 years' work experience in GMP regulated industry.