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BAYER U.S. LLC

Myerstown, PA

QA 1 2nd Shift Monday-Friday 3:00pm-11:30pm

Location120 W Jefferson Ave, Myerstown, Pennsylvania 17067
Employment TypeContractor
Date Posted2022-08-08
Direct Apply
Yes
Valid Through2023-03-02

Job Description:

Reference #: SF567141YOUR TASKS AND RESPONSIBILITIESThe primary responsibilities of this role, Quality Assurance 1 3rd Shift are to:Perform standard qualitative and quantitative analysis on;Purchased raw materials, in-process products, pure drug substances and finished pharmaceutical preparations employing accepted gravimetric and spectrophotometer procedures, in accordance with approved testing procedures of BAYER, the National Formulary (NF) and the United States Pharmacopoeia (USP).Utilize standard "bench" chemistry techniques as well as sophisticated electronic instrumentation, including spectrophotometer, viscometer, etc.Maintain records of all analysis information of assigned products on data sheets for permanent file and proper entry of information on laboratory forms;Evaluate all data obtained from the analysis, if discrepancy or deviation occurs, consult with Supervisor and recommend additional testing if necessary;Perform routine analytical and microbiological testing of raw materials purchased from prospective suppliers to determine that the materials meet compendia and/or company standards;Adhere to the pertinent aspects of Corporate and plant safety programs and adhere to GMP's, ISO standards or other regulations;Assist in investigating non-compliance investigations;Assist with troubleshooting analytical methodology and instrumentation malfunctions;Perform special assignments as directed by supervisor;Assist in validation of manufacturing and production lines and equipment pertinent to chemistry and microbiology ( e.g. equipment and room cleaning validation);Perform testing of water samples from Purified (Deionized and Reverse Osmosis) Water, USP systems;Perform microbiological environmental monitoring in production areas and in the Microbiology Laboratory Quality Assurance (QA);Audit all manufacturing and packaging documentation to ensure compliance with all GMP regulations and Bayer standards;Release raw material, bulk, and finished package component materials to ensure timely release to meet production requirements;Develop specifications for packaging components and prepare final specification sheets for new, revised, or updated components in conjunction with packaging departments, other Bayer facilities, and component vendors;Revise raw material, product, and/or general procedure monographs and participate in the controlled distribution of these documents;Initiate and/or coordinate change controls for master production documentation;Coordinate priorities with other Documentation Auditors to ensure top priority work is accomplished in timely fashion;Review production records (i.e. batch manufacturing, packaging records and MES production reports) for accuracy and completeness;Perform mathematical audit of calculations;Prepare and maintain batch jackets;Reconcile manufacturing and packaging documents for execution according to SOPs in timely manner to support production schedules;Reconcile Quality Control (QC) laboratory documentation for execution according to SOPs;Support site practices for document control in issuance/reconciliation of working documents;File new labeling exhibits, specification sheets, expiration authorizations, and storage documentation master packaging orders in appropriate files;Coordinate testing/release of work in process with production, QA and PPIC departments;Prepare and maintain essential databases, such as metal reject reports, QA product labels and release chart; copy and distribute data as needed;Maintain batch manufacturing record files according to storage procedures;Have an MBR focus to support conversion of paper batch documentation and creation of MBRs within MES;Interface with technical experts to create MBRs and convert current records to PAS-X MBR format;Maintain MBR master data by capturing and analyzing process information within the MBR - material flow, job activities, and information flow;Maintain paper and electronic records;Revise SOPs related to the use of electron

Job ID: 5400434116840649961

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