Cleanroom, Communication Skills, Current Good Manufacturing Practice (cGMP), Documentation, Equipment Maintenance/Repair, FDA Requirements, GMP (Good Manufacturing Practices), Housekeeping/Cleaning, Manufacturing, Marketing, Medical Waste, Privacy Regulations, Procedure Development, Regulatory Compliance, Sales, Standard Operating Procedures (SOP)
Production Operations Technician, GMP Sanitization
Job Description:
Position Summary
This position is responsible for GMP Cleaning and Sanitization of IgG Manufacturing areas. This includes sweeping, mopping, trash, and biohazard removal and other custodial/housekeeping duties as well as sanitization of general and environmentally controlled areas. Follows proper procedures for maintaining equipment, supplies and facilities in a cleanroom environment under cGMP. Responsible for written documentation of activities.
Essential Functions (ES) and Responsibilities
- Perform daily, weekly, monthly, quarterly cleaning in IgG areas according to defined procedures.
- Prepare cleaning solutions and rotate them per assigned procedures.
- Perform safety showers, checkups, and cleaning.
- Follow current Good Manufacturing Practices (cGMPs).
- Maintain training on all relevant procedures (SOPs).
- Maintain gowning qualification for entering Cleanrooms.
- Record all cleaning and sanitization in the appropriate logbooks.
- Perform cleaning and sanitization of IgG equipment per assigned procedures.
- Train in all relevant safety procedures.
- Remove and dispose of trash and biohazardous waste from assigned areas daily.
- Maintain all designated equipment in clean and proper working order.
- Effectively communicate status of area and any problems or issues found.
- Other duties as assigned.
- Restock all Manufacturing areas with consumable items as needed.
Job Responsibilities or Job Requirements
Competencies
FDA Adherence
Experience Requirements
Education Requirements: High School diploma or equivalent
Experience Requirements: One year previous custodial/floor cleaning experience preferred. Previous GMP experience desired but not required
Preferred Experience
Compliance Requirements (ES)
The minimum compliance expectation for this role entails strict adherence to FDA regulations and company policies governing sales and marketing activities. This includes completion of required compliance training, accurate documentation of sales interactions, and adherence to data privacy regulations. Additionally, the role requires proactive participation in compliance reviews, prompt reporting of any potential issues, and ongoing education to stay updated on relevant FDA regulations.
Job Description Footer:
In addition to competitive compensation, we offer a comprehensive benefits package including: - 401K plan with employer match and immediate vesting
- Medical, Vision, Life and Dental Insurance
- Pet Insurance
- Company paid STD and LTD
- Company Paid Holidays
- 3 Weeks' Paid Time Off (within the first year)
- Tuition Assistance (after the first year)
- Easily accessible to Tri-Rail. Free shuttle to the Boca Tri-Rail station
ADMA Biologics uses E-Verify to confirm the employment eligibility of all newly hired employees. To learn more about E-Verify, including your rights and responsibilities, please visit www.dhs.gov/E-Verify.
ADMA Biologics is an Equal Opportunity Employer.A
ADMA BIOMANUFACTURING LLC