QA Documentation Assistant - Myerstown, PA
1 month ago

Job summary
In QA Doc/Release performs usage decisions on inspection lots of packaging components and intermediates as to conformance to current good manufacturing practices cGMPs standard operating procedures SOPs and plant quality standards Review in-process records and quality assurance test results for compliance with specifications and assign disposition Review and assign expiry dating to process inspection sheets used for finished goods packaging May Include But Not Limited To The Following Coordinate priorities with other QA or SQA staff to ensure top priority work is accomplished in timely fashion May provide additional direction to contract labor support as needed Review test results and documentation associated with the receipt and testing of packaging components May accept/reject perform usage decision signature authority initiate maintain written verbal communication with packaging material component suppliers for approval of new revised specifications Prepare maintain databases assigned which may include Approved Supplier Database CofC Database AIDa Global Audit Database metal rejects release chart deviation reports product storage statements product fill requirements Gather compile QA information Support investigations batch record review accuracy completeness May perform mathematical audit calculations Requires extensive communication internal external departmental staff management complete these tasks Maintain records documentation complaint samples log book labels Write update revise SOPs area focus Prepare maintain internal Quality Principle Audit schedule entry CAPA follow up Perform audits production areas internal Quality Principle Audits Collaborate Supervisors direction inspection criteria line quality issues CAPAs etc If assigned just QA Doc Release Audit all manufacturing packaging documentation ensure compliance GMP regulations standards Release bulk intermediates package component materials timely release meet production requirements Coordinate priorities Documentation Auditors top priority work accomplished timely fashion Review production records batch manufacturing MES production reports accuracy completeness mathematical audit calculations prepare maintain batch jackets Issue reconcile manufacturing packaging documents execution according SOPs timely manner support production schedules Issue reconcile QC laboratory documentation execution SOPs Support site practices document control issuance reconciliation working documents File labeling exhibits specification sheets expiration authorizations storage documentation master orders appropriate files Coordinate testingrelease work process with Production QA SCM departments Prepare essential databases reject reports product labels chart copy distribute data needed Maintain batch manufacturing record files storage procedures Key Working Relationships Works closely one more following Supplier Quality Assurance Manufacturing sites Morristown Supply Chain Production Departments Warehouse QA personnel For QADoc release area would also interact often QAIN Alcala Bitterfeld Management Myerstown site management has broad impact across site from normal batch process working PrT issue documents qualification reports testing documents Qualifications Competencies High School degree GED at least years experience document auditing role CGMP industry required College background secretarial administrative certifications a plus Strong Personal Computer skills required Microsoft software preferred Previous experience SAP MES automated inventory system required Must excellent interpersonal written oral communication skills demonstrated ability effectively team environment Demonstrated leadership skills auditreview CGMPCGMPdocumentation various projects Demonstrate interpretive judgment accurate mathematical calculation organizational legible handwriting physically able lift pounds The Planet Group Companies equal opportunity employer celebrate diversity committed creating inclusive environment employees>
Job description
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