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Quality Assurance Auditor

Quality Assurance Auditor

Position Overview:

Promotes, support, and follow Amcor Rigid Packaging, OSHE, Quality Management Systems, cGMP and Product Safety Programs.

Essential Responsibilities and Duties:  

1.    Audit batch records (i.e. job packets) during manufacturing for compliance to product specifications, internal procedures, ISO and cGMP.
2.    Audit manufacturing equipment for operational conditions such as scrap generation, alarms, material traceability, cleanliness, metric impact, etcand escalate issues to Operations as needed.
3.    Reviews data for accuracy, data integrity and data precision.
4.    Accurately document all audits, inspections and test results in accordance with cGMP, ISO and internal procedures.
5.    Determine appropriate detection techniques, inspection methods and test procedures to verify conformance to product specifications and internal procedures.
6.    Make risk based decisions regarding the acceptance of product per procedure and established limit samples.
7.    Conduct challenge testing on downstream line equipment including CI vision, counters, leak testers and flaming to ensure proper process control is maintained.
8.    Hold and disposition product based on the results of quality testing or identified compliance violations.
9.    Review factory/product drawings and internal specifications for QIP alignment.
10.    Performs visual, dimensional, functional and environmental testing when required for incoming, in-process, finished goods and qualification testing.
11.    Assist and mentor operational personnel and quality assurance technicians as assigned to improve skillsets and increase knowledgebase.
12.    Prepares PDS/tailgates certificates and samples for shipment when required.
13.    Performs other duties as assigned by Quality Management, including Corporate QA when needed.
14.    Assist in maintaining ‘current Good Manufacturing Practices (cGMP) & ‘Good Documentation Practices (GDP) within the plant.
15.    Assist with gage calibrations and perform on demand calibrations.
16.    Generate, compile data and print-out custom reports. 
17.    Ship gages, samples, bottles, reports, etc. to customers & corporate associates.
18.    Record NCRs, hold ware & quality alerts into a database for Paretos, weekly and monthly reports.
19.    Make new defect standards & record in Quality Assurance log when required.
20.    Special projects assigned by Plant Manager or Quality Supervisor.

Qualifications:

Education:                      High School Diploma or GED
Preferred Education:     Associates degree in a quality or science related field preferred
                                         American Society for Quality (ASQ) certification preferred
Experience:                    At least 4 years experience in a Quality Assurance or related environment.  
Preferred Experience:   Previous experience in a regulated industry (i.e. Medical Device, Pharmaceuticals), clean room and plastics manufacturing environment
    Previous work experience in visual and dimensional inspection, functional testing and auditing
Knowledge and Skills:  Computer skills, proficient in Microsoft Excel and Word, Able to read and interpret work instructions, procedures, drawings and specifications
                        Good communication and decision making skills, Quality Control concepts: Sampling plans, Non-conformance, Disposition Process Control concepts: Material Traceability, Deviations, Batch Records
                          Proficient with hand measurement tools and non-contact measurement systems
                          Recognize and define problems, collect data, and develop conclusions
                          Assess root cause determinations and correlate proper immediate corrective actions
                          cGMP, GDP, GLP, Demonstrate compliance to ISO and internal QMS elements
                          Basic mathematical and statistical skills
Preferred Knowledge:  Lotus Notes, Real SPC, and SAP 
 

Amcor Leadership Framework Competencies

Core Competencies:

  • Customer Focus
  • Learning on the Fly
  • Interpersonal Savvy
  • Drive for Results

3-5 Applicable ALF Competencies:

Adaptable

Organizing

Priority Setting

Managing & Measuring Work

ADA Requirements:

Physical Requirements

☒Normal Vision

☒Distant Vision

☒Near Vision

☒Hearing/ Listening

☒ Sitting

☒Talking/Speaking

☒Hand/Finger Dexterity

☒ Walking

☒Standing

☐Stooping

☐Pushing/Pulling

☐Bending

☐Kneeling

☐Climbing

☒Lifting (amount 25+ pounds)

☐Carrying (amount 50+ pounds)

☐Driving- Forklift

☐Lifting (amount < 50 pounds)

☐Carrying (amount < 50 pounds)

☐Driving Automobile/truck/van

Work Environment: Plant Manufacturing Setting

The information contained herein is not intended to be an all-inclusive list of the duties, responsibilities, skills and/or abilities.

#CB

 

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Posted by

Contact

Amcor

Youngsville NC. 

Youngsville  NC

Posted Date: 

Close Date: 8/2/2020

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