Quality Assurance Supervisor

POSITION PURPOSE

 This position is responsible for assuring that products are being manufactured in conformance with established specifications and procedures and in accordance with regulatory requirements.  The position also provides technical support for Production Supervision and Line Operators in implementing Statistical Process Control and in maintaining a system of line / machine checks, inspection of incoming materials and finished goods, 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.

ESSENTIAL FUNCTIONS AND BASIC DUTIES

The Quality Assurance Supervisor interacts with the Analytical and Microbiology Technicians, Production, Warehouse, Compounding, Engineering, and Maintenance to facilitate the development and maintenance of process quality.  This position will provide overall direction to all Quality Assurance Technicians. 

1. Assist Quality Director in coordinating all Quality Assurance related work flow
2. Provide oversight to all quality assurance technicians
3. Oversight of all quality assurance logs and records (ex. non-conformance forms and log)
4. Daily inspection of all production lines to assure compliance to cGMPs and SOP’s.  Ensure that all manufacturing specifications are correct, clear and complete. 
5. Sample and inspect 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.
6. Accurately and completely document all inspection information on Daily Inspection Report (DIR).
7. Assure raw materials are appropriately identified and released before use in production
8.  Maintain computer data systems to reflect product release/quarantine status. 
9.  Assure that all finished goods are identified and released according to cGMP’s and Nice Pak SOP’s and Work Instructions. 
10.  Support the development and use of AQL’s as well as train supervisors and operators on AQL and trouble-shooting techniques as required. 
11. Facilitate the maintenance of documentation and tracking of nonconforming and rejected material. 
12. Notifies 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. 
13. Collect samples as required by customers or Nice Pak’s specifications. This includes any retain sampling as per manufacturing specifications and QC sample submission.   
14. Support the communication with suppliers regarding quality issues, supplying samples and corrective actions. 
15. Handle assignments as requested by supervision to establish and maintain product quality. 
16. Perform any required testing as per SOPs and WIs. 
17. Provide support to Production in all Quality efforts 
18. Order, approve and monitor the purchase of quality assurance supplies 
19. Supervise general QA Technicians coverage schedules, approve vacation, and approve timecards 
20. All other duties as assigned.

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

1. First Pass Yield
2. Internal & External Audits
3. Nonconformance Reporting Effectiveness & Timeliness
4. Quality Assurance Continuous Improvements
5. Team Dynamics/Professional Development

QUALIFICATIONS

Include minimum qualifications for formal training, education, certifications, licensures, and/or working experience.  Identify the level of knowledge; skills, and/or abilities (KSAs) required to perform the essential job responsibilities and duties competently.

 WORKING CONDITIONS 

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