What are the responsibilities and job description for the MFG Associate-Filling & Visual Inspection position at Planet Pharma?
Pay range: 22-32/hr
High School diploma or GE
Years of experience: 2
- depending on experience
- Ability to independently and accurately prepare all assigned records, calculations, and documentation.
- Demonstrated ability to independently and properly handle and dispose of hazardous waste.
- Ability to read and follow schedules, procedures, and documents.
- Demonstrated knowledge of safety precautions and procedures.
- Will be required to assist in training other employees in an area of responsibility as assigned.
- Assist staff in developing new procedures and methods or improving old ones.
- Ability to practice aseptic techniques independently.
- Ability to perform media fills with (process simulation testing) with passing results per applicable SOP.
- Ability to perform clean room gowning and pass clean room garment validation consecutively.
- Ability to independently prepare disinfectants and sanitizing solutions.
- Ability to independently clean and sanitize production equipment, rooms and areas.
- Demonstrated knowledge of an aseptic operation and the relationship of laminar flow systems and environmental monitoring.
- Ability to assist in performing environmental monitoring, such as but not limited to, independently placing settling plates and air sampling.
- Ability to use basic hand tools.
- Ability to independently set-up, operate, maintain and troubleshoot steam sterilizers, capping machines, stoppering machines, bottle washers, sterilizing tunnels, equipment washing machines, sterile filtration equipment, L bar sealers/Bundler, vision systems, inkjets, vacuum check equipment as needed.
- Ability to wear a respirator if required of the job, no pulmonary restrictions.
- Ability to independently use and understand computer assisted data entry.
- Ability to independently perform sterile filtration.
- Ability to aseptically gather and transfer samples for QC testing.
- Ability to independently perform filter integrity and prepare accurate documentation
- Basic operator functions
- New to GMP
- Ability to lift fifty (50) pounds.
- Demonstrated knowledge of:
- Federal, State, and international regulations, such as cGMP, USDA, DOT, EPA, OSHA
- Corporate guidelines and Policies related to the employee’s work.
- Standard Operating Procedures (SOPs)
- Material Safety Data Sheets (MSDSs), safety procedures, and hazardous materials procedures.
- Aseptic processing procedures related to the employee’s work.
- Team process and leadership principles.
- Appropriate processes and theory related to the employee’s work.
- Documentation related to the employee’s work.
- Equipment as defined in Duties Additional education and/or equivalent experience.
- Successful completion of National Career Readiness Work Keys assessment.
- Traffic Patterns.
- Working with BPE Methods.
- Understanding of Basic GMP/Documentation practices.
- Ability and understanding of safe working habits.
- Ability to work in a team environment.
High School diploma or GE
Years of experience: 2