Shifts:
M-TH: 4pm-2:30am
M-F: 2:45pm-11:15pm
Summary/Objective:
As a member of the Quality team, the Quality Assurance Inspector I plays a pivotal support role in a variety of day to day functions. This includes checking and documenting material and sample quality, maintaining work area sanitation/organization and transporting materials to and from departments and teams as needed.
Essential Functions:
Check for conformance of physical parameters for batches being processed on tableting and encapsulation, and coating equipment as scheduled.
Perform in-process organoleptic, hardness, thickness, disintegration, and friability testing on dosage units as appropriate.
Document all collected data promptly and correctly.
Submit finished product samples to Quality Control for analysis.
Weigh rejected materials and waste from Quality Assurance testing and from other departments. Document weights in the batch records and rejected materials log as appropriate. Assist in the maintenance of the rejected materials storage areas.
Monitor differential pressure in designated areas as per schedules. Perform clean room or equipment clearance inspections for production and packaging areas and equipment when required. Maintain logbooks in good order.
Obtain labeling materials upon request of the Packaging Department. Review and approve labeling materials prior to release to Packaging Department for use. Prepare bulk labels as required.
Program check weighing balance used to verify contents of shippers.
Complete specifications for Packaging Department as necessary to fill products.
Check counts, weight variation, torques, and physical appearance for products throughout the packaging process. Verify that packaged product corresponds with requirements as stated on the packaging master.
Obtain samples of finished products to be held as retainers. Collect and submit finished product samples as required by packaging masters and specifications.
Sample quarantined raw materials in accordance with specifications. Obtain samples for analysis, outside testing, and retainers, as indicated.
Sample and inspect incoming packaging components in accordance with specifications. Submit samples to Quality Control for further analysis, if necessary.
Prepare necessary documents and submit raw material and packaging component samples to the designated department for analysis or further processing.
Sample incoming labeling materials in accordance with specifications. Process sampled materials per requirements.
Apply release stickers as appropriate to release components.
Apply rejected stickers to materials as instructed. Assure that rejected materials are transferred to the appropriate areas for further processing.
Required Education and Experience:
High School diploma or equivalent.
Minimum of one year of Quality Assurance experience.
Fluency in the English language.
Good mathematical skills.
Preferred Education and Experience:
Degree or certification in quality, science or related field.
Supervisory Responsibility:
None
Work Environment:
Frequent exposure to fumes or airborne particles, moving mechanical parts and vibration. Occasionally exposed to a variety of extreme conditions in the plant. The noise level in the work environment can be loud.
Physical Demands:
Regularly required to use hands to finger, handle or feel; reach with hands and arms; and talk or hear. This position is very active and the employee frequently is required to stand; walk; and stoop, kneel, crouch or crawl all day. The employee must regularly lift and/or move objects up to 10 pounds, frequently lift and/or move objects up to 50 pounds, and occasionally lift and/or move objects that weigh more than 100 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.
Objects weighing 70 pounds or more must be accompanied by a second individual to avoid injury.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Travel:
None
Please note that this Job Description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
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