Sentences with phrase «batch records»

Strong attention to detail and organizational skills are required to coordinate the workflow and maintain the filing and storage of manufacturing batch records.

Perform batch record review for shipping approval.

Recorded and filed completed formulas with appropriate documentation for batch record purposes

Resolved product complaints through investigation of packaging and manufacturing processes, evaluation of batch record documentation and interactions with external supplier personnel.

Machine Operator (Manufacturing and Packaging) * Set - up, operate, change - over, and monitor equipment * Verify proper safety, GMP's, SOP's, and batch record requirements and procedures were followed

Participate in continuous improvement team to streamline packaging process and documentation needed for Master Batch Record.

Performed Batch Record calculations (including complex calculations) and maintain all documentation according to SOPs and cGMP Guide - lines.

Performed all SAP Shipping procedures and maintained detailed batch records of all outgoing product.

Review and approval of GMP documents such as batch records, engineering runs, work orders, logbooks, and reports to ensure compliance with specifications, regulations and procedures.

Issued batch records used in the encapsulation of softgel capsules produced at the plant.

Needs a bachelor's degree and has work related experience.Maintain and follow procedures, print and issue batch records, in - process labels and final product labels, support document control and document management tasks.

Documents all entries required within Batch Record and reviews Batch End paperwork for accuracy and completeness.

Titrated, formulated, and documented batch record while troubleshooting instruments, conducting uniformity tests of various reagents as well as calibrating, solution preparing, and testing chemicals using various instruments.

Recorded batch information on production tags or other documentation and completed batch record documentation.

Responsible for the review, encoding, scanning and filling of manufactured drugs batch records.

Reviewed all laboratory batch records and test results at 100 % for completeness and accuracy with no erroneous release of product as a result of a QC review failure.

Assist in the manufacturing of products in accordance with processing batch records using Bovine, Porcine, and Collagen Composite

First Amgen - Colorado quality group employee to oversee overnight manufacturing operations: ensured batch record / equipment log entries reviewed / corrected in real time; saved quality day - staff review - time and prevented possible non-conformances.

Performed manufacturing Batch Record Audits for compliance to manufacturing process, procedures, and company procedure for completeness and accuracy prior to product release, reject and or lot closure.

Reviewed and approved Equipment Cleaning Logs, Work Orders, Manufacturing Batch Records and SOPs.

Correctly populate production activities within associated batch record documentation, log books, etc..

Familiar with reading and creating batch records that give instructions on the chemicals needed to make product along with the amount needed.

Used J.D.E program to create and print batch records, along with printing pack out labels.

, New York Managed a QA team comprised of 6 inspectors Hired and trained Quality Assurance staff Hosted... process through the implementation stage Aided production of packaging machine validations Provided support... the creation and approval process of all Master Production Batch Records Approved all labels produced in

Performs data analysis, batch records review for product release and recommends disposition of materials.

So essentially, the FDA sets basic good manufacturing practices (GMPs) that require companies to identify the raw materials in their supplements and test for things like purity and potency and keep detailed batch records.

Scanning of quality documents such as batch records, deviations, change controls and related documentation

Eon Pharma, LLC, Laurelton • NY 2000 — 2004 Administrative Assistant Provided administrative support for high volume Pharmaceutical Company with oversight for batch records, and developed and recorded product specification data sheets.

Quality at the source utilizing on the floor real time batch record review, disposition batch record review, disposition and in process auditing.

Review batch records and... more

Draft SOPs, CAPAs, DCR and batch records.

Supervised 6 Manufacturing QA Inspectors conducting the in - process testing and inspections, line clearances, batch record review and final batch releases in coordination with other QA sections performing the chemical, biological and physical controls of each lot produced

Sample resumes for this position highlight skills like recording and documenting SOP / GMP forms and batch records, and compiling and analyzing test information for out - of - spec instruments.

Strong interpersonal and communication (both oral and written) skills; interact with various departments; able to work independently and as part of a team; proficient computer skills; review of documentation, protocols, and batch records; initiate and review of change control records, initiate and review of investigation reports.

Conduct internal audits, supplier / contract (3rd party) manufacturer audits, and allograft (batch record) file reviews.

Lead the analysis of the Batch Record requirements and developed EMBRs, design documents and test scripts in accordance with SOPs (Standard Operating Procedures), SME (Subject Matter Experts) input and QA (Quality Assurance) input.

Batch Record Review GMP Document Control + Support manufacturing services through the review and approval of master batch records and completed manufacturing records for review, approval, and release...

Perform Granulation, Blending, Drying and Coating on dispensed chemical materials for manufacturing of Oral Liquid Suspension dosage forms in immediate and extended versions as per SOP, batch records and follow D.E.A. rule and regulations.

Contributed on development of work instructions, batch records, equipment logs, material specifications and other device history documents.

Review batch records (BR), Standard Work Instructions (SWI) Client Work Instruction and Standard Operation Procedure.

Tags for this Online Resume: QA, Audits, GMP, FDA, Quality, Compliance, ELISA, Manufacturing, Therapy, Cancer, oncology, pharmaceutical, Batch Record, Immunotherapy, Drug product, Drug substance

Tags for this Online Resume: HPLC, UV Spectrophtometer, Clean Room, GMP, Batch Record, SOP, Stability Test, pH Test, Blood Draw

Perform routine quality audits of controlled manufacturing areas for material identification, traceability, equipment calibration Inspect raw materials, finished subassemblies and assemblies according to procedures and specification.Review QC data packets and batch records for completeness.