Role Summary
Specialist, Production Cleaning is responsible for performing microbial control cleaning in facilities that manufacture a finished product for sale, or sale to another organization for use in an end product. Cleaning procedures must comply with current Good Manufacturing Practices (cGMP) and regulatory guidelines, with documentation of work procedures frequently audited by the FDA and other regulatory agencies. The work is performed under the general supervision of Lead Personnel and an Area Supervisor.
Responsibilities
- Performs cross contamination cleaning methods in areas that require microbial control.
- Completes cGMP documentation of training or cleaning performed on paper and electronic devices.
- Prepares cleaning solutions based on cGMP regulated mixing instructions.
- Performs microbial control cleaning techniques on walls, ceiling and floors based on cGMP regulated cleaning frequencies.
- Completes preventive maintenance work orders to meet cGMP cleaning requirements.
- Follows specific gowning procedures and performs cGMP entrance and exit procedures for controlled environments.
- Operates bailing and compacting equipment.
- Operates various types of handheld battery and electric cleaning equipment.
- Operates various types of battery and electric walk behind or ride-on floor cleaning equipment.
- Performs safety and preventive maintenance inspections on housekeeping power equipment and small tools and wears approved PPE.
Qualifications
- High School Diploma or GED required.
- Must be able to read and comprehend written information to include Corporate Quality Documents, Divisional Operating Procedures, Departmental Operating Procedures and Safety Guidelines.
- Must be able to comply with cGMP, regulatory guidelines and able to write legibly in English and complete accurate and legible written records in compliance with cGMP when documenting work performed, on paper documents and electronic devices auditable by regulatory agencies.
- Must be able to operate a computer to complete required compliance & technical training.
- Must have the ability to learn and perform cleaning techniques to meet regulatory requirements.
- Must have the ability to work alone or as a team member sharing responsibility and work tasks.
- Must be able to perform all cleaning specialist job functions.
Additional Requirements
- Basic physical requirements are but are not limited to: stand for 7 hours per shift, regularly lift 35 pounds 50 times per shift, occasionally lift 50 pounds 6 times per shift, walk approximately 2000 feet per hour, climb 6 flights of stairs per shift, work on knees 30 minutes per shift, bend / squat 200 times per shift, rotate left / right 200 times per shift.