Fladger Associates ยท 1 day ago
GMP cleaner
Fremont, CA
Contract
Onsite
Entry Level
1+ years expFladger Associates is seeking a Manufacturing GMP Cleaner in the Fremont, CA area. The role involves performing and coordinating GMP cleaning and sanitization of process areas on the manufacturing floor, ensuring compliance with established regulations and safety standards.
Staffing & Recruiting
Hiring Manager
Bhavna pal
Responsibilities
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 Boehringer and Boehringer 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
Qualification
Required
High School Degree
1-2 years' work experience in GMP regulated industry
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
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
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
Workers must successfully complete a respirator fit test as wearing a respirator will be required for this position
Preferred
Moderate technical knowledge of biologics operations is preferred
Company
Fladger Associates
Fladger Associates is a professional, national executive search and human capital solutions firm specializing in licensed, degreed, or certified professionals in: .
11-50 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase