Quality Assurance Tech 1 Job at Nice Pak Products, Inc.
POSITION PURPOSE
This is a safety sensitive position.
The Quality Assurance Technician interacts with the Analytical and Microbiology Technicians, Production, Warehouse, Compounding, Engineering, and Maintenance to facilitate the development and maintenance of quality systems. This position is also responsible for assuring that incoming raw materials and finished goods are being sampled in conformance with established specifications and procedures and in accordance with regulatory requirements.
ESSENTIAL KSA’S (KNOWLEDGE, SKILLSET AND ABILITIES)
This position is responsible for assuring that the materials being used, and products being manufactured are in conformance with established specifications, procedures and in accordance with regulatory requirements. The position also provides technical support for Operations leadership and Machine Operators in implementing Statistical Process Control and in maintaining a system of line / machine checks, inspection of incoming materials and finished products, internal audits and in the completion of appropriate documentation. A key responsibility of this position is the identification of nonconforming products or processes, and leadership in continuous improvement efforts. The QA Tech must also possess the knowledge, skills and abilities to complete the following essential job functions and responsibilities:
- Complete daily inspections of all production lines to ensure compliance to Good Manufacturing Practices (cGMPs) and Standard Operating Procedures (SOP’s).
- Ensure that all manufacturing specifications are correct, clear and complete.
- Audit cleanliness of machinery and operator’s attire.
- Sample, inspect and test in-process, finished products, returned and reworked material for quality. Determine final disposition on inspected products. Apply appropriate disposition label (via physical and virtual warehouse management systems) to material.
- Accurately and completely document all inspection information on Daily Inspection Report (DIR).
- Ensure raw materials are appropriately identified and released before use in production
- Maintain computer data systems to reflect product release/quarantine status.
- Ensure that all finished goods are identified and released according to cGMP’s and Nice Pak SOP’s and Work Instructions (WI’s).
- Support the development and use of Acceptable Quality Limits (AQL’s), as well as train Operations leadership and Machine Operators on AQL and trouble-shooting techniques as required.
- Facilitate the maintenance of documentation and tracking of nonconforming and rejected material.
- Notify and follow through with production and Quality when variations from procedures and specifications are observed. This function includes identifying non-conforming material, recording of it and distributing required documentation.
- Collect samples as required by customers or Nice Pak’s specifications. This includes any retain sampling as per manufacturing specifications and QC sample submission.
- Handle assignments as requested to establish and maintain product quality.
- Perform any required testing as per SOPs and WI’s.
- Provide support to Production in all Quality efforts
- Maintain accurate, complete and traceable documentation of raw materials. Keep accurate paperwork on any finished goods or raw materials inspected.
- Complete physical and graphics inspections of raw material samples as needed to support 24/7 operations.
- Generate Rework packet documentation and ensure operations personnel understand the rework requirements
- Provide samples for analytical and/or micro testing.
- All other duties as assigned.
QA Tech 2 – The Quality Assurance Technician 2 performs all the functions of the Quality Assurance Tech and must satisfy additional training requirements to demonstrate they can perform the following job functions and are competent in the following KSA’s:
- Perform QA Location audits and reconciliation.
- Provide GMP, GDP coaching to operators.
- Conduct root cause analysis on major non-conformances and customer complaints.
- FPY tracking and reporting for line and shift.
- Complete investigations/CAPA issued to QA.
- Create/Revise Procedures/VMS’s.
- Verification of new QAT Training effectiveness.
- Complete rework packet reconciliation
- Create/Revise Operator Control Plans.
- Participate in the internal audit program.
- Understands and demonstrates the Sample Pull Process (time and Quantity).
- Must demonstrate proficiency with WMS.
- Independently makes quality decisions on day to day outages.
- Possesses a full understanding of the AQL process and documentation
- Proficient in the Non-conformance process, documentation and Master Control routing.
- Proficient with Customer complaint retain pulls, inspections, data collection and documentation
In addition, the following criteria must be met for a QAT to be eligible to advance to QAT2:
- Minimum 12 months in the QAT role
- Meets or exceeds goal expectations in previous year performance review and currently in good standing.
- Meets or exceeds competency expectations in previous year performance review performance reviews
- No written disciplinary actions within the last 12-month period
The above is intended to describe the general content of and requirements for the performance of this position. It is not to be construed as an exhaustive list or statement of duties, responsibilities or requirements.
PERFORMANCE MEASUREMENTS
- Safety
- First Pass Yield
- Line Efficiency
- Customer Service
- Contributes to general continuous improvements
QUALIFICATIONS
- High School Diploma or equivalent
- Understanding of basic statistical concepts
- Understanding of cGMP and GDP environment
- 1-2 years of experience in manufacturing
- Proficient computer skills: Microsoft Office, BPCS
- Excellent communication skills, both verbal and written
WORKING CONDITIONS
#LI-DC1
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