Position will train on day shift, M-F 6am - 2:30pm. Long term may transition to 2nd shift, M-Thurs 1:30 pm - 12 midnight.
PURPOSE OF THE POSITION
To semi-automatically and automatically portion chemicals into containers, automatically and manually cap and label those containers per packaging specifications. Complete appropriate packaging documentation per FDA, ISO and GMP procedures and deliver products to inventory.
??? Fill, cap and label chemical products
o Independently set-up and operate automated fill lines
o Perform routine maintenance and minor repairs to semi-automated equipment
o Organize and set-up the filling of large hazardous fills using equipment
o Trouble shoot automated and semi-automated cappers
o Manually fill liquids or powders
o Utilize semi-automated equipment to fill liquids or powders
o Fill products utilizing aseptic technique
o Perform fills in environmentally controlled areas
o Fill hazardous products
o Transfer bulk utilizing peristaltic pumps
o Filter bulk material using pumps and in-line filters or vacuum filters
o Operate automated and semi-automated cappers
o Manually torque caps with wrenches as necessary
o Assist with loading bottles and pack-off during fill line operation
o Set up and operate automated labelers
o Hand label as necessary
??? Follow all quality and safety procedures. Support quality systems.
o Train operators on semi-automated filling equipment
o Follow safety procedures at all times
o Document all equipment used and verify calibration status
o Don, doff, use and clean personal protective equipment appropriately
o Be familiar with hazards common to assigned work and take action to correct unsafe situations
o Participate in required safety activities such as training sessions, meetings, and safety inspections.
o Develop and assist in the implementation of process improvement ideas
o Train operators on general packaging, quality, and safety practices and documentation
o Comply with the requirements of ISO 13485 and ISO 9001
o Participate in building and departmental 5S activities. Maintain good housekeeping and audit readiness.
??? Assemble and package chemical kits
o Package Kits
Working hours: 6 AM - 2 PM
High School Diploma or equivalent. College level chemistry coursework is desirable.
Experience: Related chemical packaging or scientific/laboratory experience or training is required. Experience in ISO 13485 and GMP facilities desirable.
Knowledge and Skills:-
Ability to set-up and troubleshoot automated packaging equipment
Safe chemical handling methods
Verbal and written communication skills
Strong PC skills
Mechanical skills including the ability to use pumps, electronic balances, and material handling equipment
Ability to train others and work in a team setting
Good time management and organizational skills
Strong math skills including metrics and conversions
Knowledge of ISO and GMP quality standards
ADDITIONAL LOCAL NEEDS
Extended periods of standing and repetitive movements. Working with and in proximity of hazardous chemicals and human source materials.
While performing the duties of this job, the employee frequently is exposed to fumes or airborne particles and reactive, toxic or caustic conditions. The employee occasionally is exposed to extreme, non-weather related cold and heat, wet humid conditions, and vibration. The employee may work near moving mechanical parts. The noise level in the work environment may be loud.
While performing the duties of this job, the employee is regularly required to walk, reach above the shoulders, use feet to operate equipment and stoop, kneel, twist, crouch or crawl. The employee is frequently required to use hands to handle materials and operate tools and equipment and stand. The employee may be required to wear an air helmet, mask, safety shoes, apron rubber and tyvek suits, protect gloves, and safety glasses and goggles while performing in this position. The employee must occasionally lift and/or move up to 70 lbs. Specific vision requirements of this job include close vision, distance vision, color vision, peripheral vision, depth vision and the ability to adjust focus.
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