The Quality Assurance Technician 1 is responsible for the inspection of Raw Materials to ensure conformance to specifications.
Essential Duties & Responsibilities
• Inspect raw materials at receipt to verify conformance to specifications.
a. Reviews Supplier C of A’s against NAI specifications.
b. Determines when testing is due based on testing history and NAI specification testing frequencies.
c. Takes samples of raw materials using statistical sampling plan and utilizing aseptic technique.
d. Performs physical inspection and testing, as required, such as identity testing using FT-IR analyzer, loose
and/or tapped density, Loss on Drying using a moisture analyzer, sieve analysis using various screens with
Ro-tap equipment and irradiation screening using PPSL equipment.
e. Perform secondary review of inspection documentation
f. Release conforming material for production use.
• Complete and file required documentation.
• Communicates inspection failures and non-conformances to QA Coordinator.
• Follows management instructions for handling non-conforming material or product.
• Understands and follows company procedures and policies for inspecting materials and finished product established in compliance with the 21 CFR 111, Dietary Supplement cGMP.
• Understands and follows written instructions provided in company procedures and specifications. Notifies QA Manager of any
deviations to the procedure or specifications. Obtains instructions and approval for handling deviation prior to initiating action.
• Able to communicate and inter-act effectively with Purchasing, Planning, R & D, Distribution, Inventory Control, Operations, Client
Services and Quality personnel
• Maintain a sanitary working environment.
• Control & Coordinate the movement of material.
• Assists with Raw Material Retain management
• Assists with Temperature and Humidity Monitoring Program
• Assists with Raw Material quarantine cage maintenance
• Performs other jobs as requested.
•Education & Experience Minimum: High School Diploma with 2 years Quality experience, or BA/BS degree in biology, chemistry, engineering or applicable physical science.
• Proven knowledge of interpreting microbiological and analytical test results reported on C of A’s.
• Proven knowledge and ability to conduct and interpret inspection criteria, data, and results.
• Strong communication skills and the ability to follow both written and verbal instructions.
• Ability to document information completely and accurately.
• Ability to multi-task in a fast paced environment.
• Good computer skills, with knowledge of Microsoft word, access, and excel.
• While performing the duties of this job, the employee is regularly required to walk; use hands to finger, handle, or feel; reach with hands and arms; stoop and kneel; talk and hear. The employee is frequently required to sit and stand.
• Specific vision abilities required by this job include close vision, color vision, peripheral vision, depth perception, and the ability to adjust and focus.
• Lifting requirement: Up to the maximum safety-recommended 50 pounds
The physical demands are representative of those that must be met by employee to successfully perform the essential functions of this job. Reasonable accommodations may be made upon request to enable individuals with qualified disabilities to perform the essential functions of the job.
Employee will be required to train on Standard Operating Procedures (SOP), Safety and Good Manufacturing Practices (GMP).
Employee will make decisions related to raw material evaluations and conformance with specifications.
Employee must demonstrate strong communication skills both written (via email and memo) and verbal. Employee will be required to communicate with QA Management and multiple NAI departments.
Results of Action
Decisions on status of raw materials will determine if material is acceptable for use.
FT-IR (ID testing), Sampling tools, particle size analyzer, PPSL tester, bulk density/tapped density tester, moisture analyzer, disintegration equipment, cylinders, weigh pans, petri dishes, personal computer and multiple printers.
Production facility where exposed to computerized equipment, moving mechanical parts, forklifts, heavy pallets, moderate to loud noise level, and air-borne dust and powders. While working, will be required to wear various personal protective equipment (e.g., clothing, hair net, face mask, gloves, goggles, etc.).