GMP Operator – Commercial Manufacturing

Published
June 24, 2022
Location
Boothwyn, PA
Category
Job Type

Description

*Description:*GMP operations in the daily execution of Manufacturing GMP, and Clinical batches; cleaning/sanitization procedures and support functions of equipment, facilities and instruments.Main tasks and responsibilities will include:Facility Sanitization & Equipment Cleaning ProceduresWeighing and Manufacturing of GMP, R&D and Clinical BatchesEquipment Staging, Setup, Operation, Disassembly and Cleaning with no supervisionPerformance Verification/Calibration of InstrumentsMaterial HandlingTraining and Mentoring New and Current GMP AssociatesExecution of GMP, R&D and Clinical batch records with minimal or no supervisionAuthors and reviews GMP equipment Standard Operating Procedures (SOPs)Proficient in Batch Record ReviewAdditional responsibilities include:Execution of manufacturing batch records and material samplingCarries out duties in compliance with all state and federal regulations and guidelines including FDA, EPA, OSHA and DEA.Complies with all company and site policies and procedures.Makes a positive contribution as demonstrated by:Making suggestions for improvementProviding overtime as needed- performing all tasks related to the manufacture of oral solid dosage drug products with minimal supervision (i.e. coating, tablet press, encapsulation, granulation, drying, milling, blending, compression, and bulk packaging operations).- Establish/exemplify a sense of urgency in completing daily activities.- Executes and documents master batch formulas and logbooks at the highest level of cGMP compliance with minimal supervision.- Perform physical In-process attributes on all products manufactured.- Verify accuracy and calibration of all Equipment and in-process testing devices used in manufacturing processes.- Set-up, operate, break down, clean and sanitize equipment and production rooms as per SOP's, protocols and any provided trainings.- Ability to troubleshoot equipment and perform any operational maintenance.- Coordinate efforts with QA as required.- Submit all In-Process or Release Samples to either Quality Control or Quality Assurance for testing as needed.*Skills:*production, pharmaceutical, assembly, distillation, cgmp, pharmaceutical industry, formulator, GMP, granulator, tablet press, encapsulation, encapsulator, compression, coating, blending, milling, solid dosage*Top Skills Details:*production,pharmaceutical,assembly,distillation,cgmp,pharmaceutical industry*Additional Skills & Qualifications:*- High School Diploma or GED required- 1+ years of pharmaceutical experience specifically within Pharmaceutical operations (manufacturing, operator, packaging, lab, etc.)- Experience in a cGMP environment- Capable of Reading and Writing to a standard that aligns with GDP's.*Experience Level:*Intermediate Level About Actalent: Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

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Allegis Group

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