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Associate Scientist II, Quality Assurance - Raw Materials

Company: PTC Therapeutics
Location: Pennington
Posted on: June 12, 2021

Job Description:

Job Description:Responsibilities:Lab responsibilities include raw material testing and release, sampling of raw materials, and disposition of consumables:Methods of testing include FTIR, Raman, HPLC-CAD, Description, Osmolality, pH, wet chemistryDevelops novel testing methods for the identification of raw materialsPerforms method and material qualifications and validationsAides in the sampling and disposition of raw materialsPerforms manufacturing consumable and processing aids inspections and releaseMaintains sample and reference material inventoryQualifies and validates new laboratory instrumentationSupports activities related to vendor/material approval and management of Contract Testing Laboratories:Authors and reviews new specifications for raw materials and consumablesData and material management via electronic systems such as LIMS and SAPManages outsourcing of raw materials for Contract Lab TestingAuthors or revises procedural SOPs and testing methodsParticipates in Vendor Audits and the review of quality agreementMay contribute to and participate in vendor change notification program.May assesses new incoming raw materials and proposes testing plans.Supports QA system and procedure changes to enhance overall job performance and QA functions.Maintains electronic and paper-based documentation, as needed.Performs other tasks and assignments as needed and specified by management.Qualifications:Masters degree in a related scientific discipline and a minimum of 4 years of relevant experience in a QA, logistics or related role OR a Bachelors degree in these same disciplines and a minimum of 6 years of relevant experience.Detailed/Demonstrated knowledge and understanding of GMP regulations and Food and Drug Administration (FDA) requirements.Experience with SAP, LIMS, ELN, Veeva Vault Quality Document Management System or equivalentWorking knowledge of global pharmacopeias such as USP, EP, JP, BP, Ph. Eur.Knowledge of biopharmaceutical manufacturing process workflowsProficiency with Microsoft Office and Excel.Excellent verbal and written communication skills.Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.Experience working directly with the FDA or other health authorities preferred.QC laboratory experience preferred.Experience with Quality Risk Management and Quality Management Systems such as Deviation Investigations and CAPAs preferred.Travel requirements: 0-15%Office/Laboratory-based position. Requires the ability to lift items weighing up to 15kg.

Keywords: PTC Therapeutics, Trenton , Associate Scientist II, Quality Assurance - Raw Materials, Other , Pennington, New Jersey

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