Job DescriptionDate 05/2018 Location 1300 Airport Road, North Brunswick NJ Title Associate, Tablet Inspection Department Standard Manufacturing Reports to Supervisor, Production FLSA (Exempt or Non-Exempt Non-Exempt Role Overview The Inspection Associate is an entry-level position responsible for the inspection of tablets and capsules. They will identify any physical defects or foreign objects in accordance with company standard operating procedures (SOPs) and cGMP regulations and ensure products meet applicable quality standards. Areas of Responsibility
- Ensures full compliance with Company policies, procedures, GMP's, Ethical Business Practices, and SOP's at all times.
- Ensures that product meets applicable quality standards. This includes inspection for quality during operation and performing all required sampling and testing.
- Ensures that product meets applicable quality standards and checks for:
1) Tablet issues such as chipping, sticking & picking, coating quality, black spots, delamination; and 2) Capsule issues such as: denting, splitting, and not closing properly.
- Following the completion of visual inspection and sampling, operators repack tablets and capsules into corrugated boxes.
- Maintains data in Batch Manufacturing Records (BMR) and logbooks to ensure they are fully completed, signed, and in compliance with company standards and regulatory requirements.
- Disassembles cleans/sanitizes, and reassembles all required equipment.
- Work as a team to examine approximately 500,000 tablets per shift
- Maintain proper gowning and hygiene to ensure the integrity of the product as per cGMP's and company policies.
- Must be able to work extended work hours and weekend overtime.
Other Responsibilities Including Safety:
- Works in a safe and responsible manner to create an injury-free and incident-free workplace.
- Complies with all job-related safety and other training requirements.
- Keeps management informed of area activities and of any significant problems.
RequirementsEducation & Qualification:
- High school graduate or GED equivalent
- 6-12 months of work experience preferably in a manufacturing environment
- Requires clean, neat handwriting
Certifications, Licenses, and Credentials:
Skills & Ability
- Demonstrates ability to work in a team and assist others.
- Able to follow written instructions precisely to detail and accuracy with numbers.
- Basic understanding of cGMP and OSHA standards etc.
- Demonstrates the ability to read and write basic English in order to be able to understand the industry-regulated instruction sheets.
- Able to identify imperfections in all products and has good visual acuity
Physical Requirements (lifting, etc.):
- Ability to lift up to 35lbs.; occasionally lift and move up to 50 pounds.
- Must stand and walk on the production floor for a minimum of 6 hours per shift
- Uses hands to finger, handle, feel, or operate objects or controls, lifting to waist height and/or above shoulder height, frequent bending from the waist, or squatting, walking short distances.
- Occasionally works from a rolling ladder or step stool, must be to lean over equipment as well as kneeling on the floor to clean under the equipment.
- Must be able to wear all PPE including a lab coat, face mask, booties, gloves, safety glasses/goggles, and respirators.
Work Environment (Office, Warehouse, temperature extremes, etc.):
- Work is regularly performed inside a manufacturing environment where temperatures can be moderate, and exposure to dust, odors, noise, and fumes. The noise level is usually moderate. Employees can be exposed daily to chemicals and cleaning agents.
The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. They are not intended to be an exhaustive list of all the job responsibilities, duties, skill, or working conditions. In addition, this document does not create an employment contract, implied or otherwise, other than an at will relationship.