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.
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
3-5 Applicable ALF Competencies:
Managing & Measuring Work
☒Lifting (amount 25+ pounds)
☐Carrying (amount 50+ pounds)
☐Lifting (amount < 50 pounds)
☐Carrying (amount < 50 pounds)
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.
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Alert Notice time 11:25 AM
Today Jul 16, 2020