Description/Job Summary

　　SUMMARY OF POSITION: The person in this role reports to the Plant Manager and is responsible for leading quality improvement initiatives. Conducting routine analysis following defined methods in support of raw material production, procurement and refinement. Day-to-day responsibilities include auditing of daily production paperwork, identification of non-conforming materials, verification of procedural proficiencies within manufacturing, sampling and sample preparation, operation and maintenance of analytical instrumentation as assigned, data management/reporting and maintenance of a clean laboratory environment.

　　ESSENTIAL FUNCTIONS:

　　Responsible for oversight, management and leadership of all QA responsibilities and external auditing, investigations, CAPAs, change control, document control

　　Observe all safety precautions and regulations. Be proactive in addressing safety issues and concerns.

　　Routine analysis of materials using defined methods.

　　Facilitate the training and development of Quality and Production personnel in regards to quality assurance methods and procedures.

　　Perform internal audits on Finished Goods, Production Records, and Manufacturing Processes.

　　Assist with the development and implementation of procedures related to Production and Quality.

　　Work with the Production to ensure compliance with all audit standards.

　　Operate and maintain laboratory instrumentation.

　　Keep complete and accurate records of laboratory activities.

　　Responsible for data management including accurate transcription to spreadsheets or other software.

　　Protect the integrity of test samples by maintaining a clean and orderly laboratory environment.

　　Promote quality achievement and performance improvement across the organization.

　　Ensure waste materials are discarded in their designated containers.

　　Responsible for interfacing with FDA and other regulatory agencies relating to GMP inspections, pre/post product approval inspections.

　　Identify, coordinate and implement systems that ensure cGMP compliance and continuous improvements.

　　Lead internal and external audit activities

　　May be required to perform other duties as requested, directed or assigned

　　REQUIRED SKILLS

　　Working knowledge of the operation, calibration and preventative maintenance of laboratory equipment.

　　Skilled in sample preparation methodology.

　　Working knowledge of the CAPA process.

　　Working knowledge of 3rd party audits/audit procedures.

　　Working knowledge of basic calculations and formulas in MS Excel.

　　Analyze charts and graphs to find trends.

　　Perform effectively in environments with frequent workload changes and competing demands.

　　Work independently and follow through on assignments with minimal direction.

　　EDUCATION & EXPERIENCE:

　　High school diploma required

　　BS or related degree preferred or 3-5 years' experience in Quality Control/Assurance

　　Proficiency with Microsoft Products.

　　Excellent communication and interpersonal skills. Establish and maintain cooperative working relationships with individuals at all levels of the organization.

　　Experience in training employees and encouraging self-sustained.

　　Good organizational skills with the ability to prioritize and handle multiple tasks.

　　Demonstrate ability to manage multiple tasks and demands

　　Knowledge of GMP and SQF

　　WORKING CONDITIONS:

　　Willing to work in a team-oriented, fast-paced environment.

　　Must perform work efficiently and effectively under short notice.

　　Will sit, stand or walk short distances for up to the entire duration of a shift

　　Will climb stairs on an occasional basis.

　　Will lift, push or pull up to 40 pounds on an occasional basis.

　　Required to use hands to grasp, lift, handle, carry or feel objects on a frequent basis.

　　Must comply with all safety standards and procedures.

　　May reach above shoulder heights and below the waist on a frequent basis.

　　May stoop, kneel or bend on an occasional basis.

　　Must wear personal protective equipment as required (including but not limited to; steel toed shoes, cut resistant gloves, safety glasses, hearing protection, arm guards

　　ENVIRONMENT CONDITIONS:

　　Inside environmental conditions protected from weather conditions

　　Outside environmental conditions, no effective protection from weather.

　　Inside and outside environments apply.

　　Subject to extreme heat; temperatures above 100 degrees for more than one hour.

　　Subject to noise, causing reason to shout to be heard above the noise level.

　　Subject to vibration, exposure, fluctuating movement of the body.

　　Subject to hazards such as moving machinery, electrical currents, falling debris, exposure to chemicals, gases, high heat or explosives

　　Subject to unregulated atmospheric conditions caused by odors, fumes, gases, poor ventilation and dusts.

　　Subject to oils and other cutting fluids via touch or air.

　　Air density conditions causing the use of a respirator.

　　Not exposed to any adverse environmental conditions. (Usually office work.)

　　SQF RESPONSIBILITY

　　The SQF Practitioner is responsible for managing the SQF Food Safety Code for Manufacturing of the Food Packaging.

　　Ensure GMP are exerted throughout the production process

　　Ensure production process follows SQF Code

　　Fully proficient with SQF Code and executing audits, trained as backup to the Operations Manager.