2nd Shift Hours: 3:00pm-11:00pm. SUMMARY. Function as lead associate responsible for verifying that all systems and processes are compliant with Work Instructions and Company requirements in order to begin and/or finish production activities within a specified room or rooms. Throughout production conduct attribute inspections, asset verifications and component delivery and removals according to the requirements outlined in the associated Batch Re...
SUMMARY. Under the direction of the Audit Manager, the Quality Auditor has the responsibilities for hosting customer audits, conducting supplier audits, and conducting internal cGMP compliance audits for the company. This role encompasses the entire audit process including support in regulatory and third-party audits. The Auditor responsibilities encompass Sharp Packaging Services, LLC commercial US facilities (Allentown, Conshohocken, and Macung...
SUMMARY. The Quality Assurance Manager- leads a team of quality professionals that provide quality oversight, GMP guidance and support and make quality related decisions for the designated functional areas within the Sharp Commercial sites. Responsibilities include but are not limited to the supervision of quality activities, assessment for new and ongoing projects, provide direction for cGMPs to direct reports and make recommendations on resolut...
SUMMARY. The QA Electronic Batch Record (EBR) Lead will be responsible for leading the implementation, validation, and ongoing maintenance of the Manufacturing Execution System (MES) and support applicable EBR systems within GMP operations. This role ensures the EBR system is compliant and efficient batch execution, documentation, and review. Serves as Subject-Matter-Expert (SME) between Quality, Operations, Validation and IT. Supports integratio...
SUMMARY. Under the direction of the Audit Manager, the Quality Auditor has the responsibilities for hosting customer audits, conducting supplier audits, and conducting internal cGMP compliance audits for the company. This role encompasses the entire audit process including support in regulatory and third-party audits. The Auditor responsibilities encompass Sharp Packaging Services, LLC commercial US facilities (Allentown, Conshohocken, and Macung...
SUMMARY. The Quality Assurance Manager- leads a team of quality professionals that provide quality oversight, GMP guidance and support and make quality related decisions for the designated functional areas within the Sharp Commercial sites. Responsibilities include but are not limited to the supervision of quality activities, assessment for new and ongoing projects, provide direction for cGMPs to direct reports and make recommendations on resolut...
SUMMARY. The QA Electronic Batch Record (EBR) Lead will be responsible for leading the implementation, validation, and ongoing maintenance of the Manufacturing Execution System (MES) and support applicable EBR systems within GMP operations. This role ensures the EBR system is compliant and efficient batch execution, documentation, and review. Serves as Subject-Matter-Expert (SME) between Quality, Operations, Validation and IT. Supports integratio...
Summary. Represents Sharp’s Engineering functions related to new business development projects and strategic Capital programs at all Sharp facilities and acts as the project lead for all Engineering functions deployed in support of new business projects and initiatives. Plans, directs, and coordinates activities involved with design, specifications, estimating, procurement and implementation of equipment, tooling and technology used to support ne...
SUMMARY. Primary responsibilities include operations support in setup, maintenance, and operation of high-speed automatic packaging equipment. Electromechanical troubleshooting skills are required to effectively support and assist in the maintenance and operation of automated packaging equipment. Maintains a cGMP production environment and standards throughout the production area(s). Adheres to workplace environmental, health and safety (EHS) gui...
SUMMARY. Responsible for performing all duties related to the daily operations of onsite warehousing, which include Receiving, Shipping, Order Picking, Materials Management and Housekeeping. ESSENTIAL DUTIES AND RESPONSIBILITIES. The following is a list of minimum responsibilities related to the Warehouse I position. Other duties may also be assigned. Coordinates and verifies all finished good shipments are staged, labeled, counted, and 100% insp...
Conducts all activities concerned with the design, development and implementation of secondary and tertiary packaging containers by performing the following duties. Review Design Request paperwork and customer packaging/product specifications with Account Executives. Provide all design related information to Estimating in a timely manner to facilitate the estimate process. Advise Account Executives and/or customers on efficient packaging procedur...
SUMMARY. Primary responsibilities include operations support in setup, maintenance, and operation of high-speed automatic packaging equipment. Electromechanical troubleshooting skills are required to effectively support and assist in the maintenance and operation of automated packaging equipment. Maintains a cGMP production environment and standards throughout the production area(s). Adheres to workplace environmental, health and safety (EHS) gui...
