AMRI Manager, Quality Control Analytics in Burlington, Massachusetts

The Quality Control Analytical Manager is responsible for performing routine and non-routine analytical chemistry assays of raw materials, in-process samples, finished formulations, and special projects. The manager is also responsible for coordinating and performing method development, validation, and transfer activities. The QC Analytical Manager oversees as staff of Quality Control Chemists.

*_Position Responsibilities

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/Other duties may be assigned/__

· ManagetheQualityControlTeamPerformanceofanalyticaltestingforincoming,in­ process and final products, and stabilitysamples.

· Ensure that the analytical chemistry functions are completed in accordance with the Companyandgovernmentalstandardsofsafetyandquality,andthatallexperimental documentation is complete andtimely.

· Superviseateamofscientistsincluding,butnotlimitedto,themotivation,education, efficiency,performancemanagementandproductivityoftheseindividuals.

· Build a sense of customer confidence in departmental results. Will be responsiblefor providingliaisoncommunicationwithkeymembersofclientorganizations.

· Communicateeffectivelyinbothverbalandwrittenformonresults,issuesandplans.This mayinvolveandincludecloseinteractionswithcustomers.

· Ensure that laboratory operations are conducted in a safe manner. Remain familiar with the contents of the Chemical Hygiene Plan. Follow safety rules fully.

· Maintain compliance with regulations at all levels as well as strict adherence to standard operating procedures and cGMP’s as necessary

· Organize workload and coordinate activities in order to carry out multiple projects concurrentlyandinaccordancewithestablishedobjectives,timelinesanddeadlines.

· ManagetheperformanceofQCanalyticalchemistryassays,HPLC, GC,IR,TOC,Particle Size and wet chemistryassays.

· InvestigationsofOOS,DeviationsandChangeControlManagement.

· BackupforQCanalyticalinstrumentmaintenance,calibration,andvalidation.

· CoordinationandperformanceofQCmethodqualifications,validations,andtransfers.

· ManagetheperformanceofQCmethoddevelopmentandcleaningvalidationstudies.

· Backup forQCanalyticalsamplereceiptforinternaltesting,outsidelaboratorytesting, login,processing,shipment,tracking,distribution oftestresults,andclosure.

· Authoring and revision ofQCSOPsandtestprocedures.

· Authoring of validation and transfer protocolsandsummaryreports.

· Mentorship and training of team membersonapplicabletechniquesandequipment.

Education:Bachelor’s degree in Chemistry or a scientific discipline with relevant coursework or work experience in analytical chemistry

Relevant Work Experience:5-8 years’ experience in a GMP or FLP environment, working with HPLC, extensive method development and validation. Previous supervisory experience strongly preferred

Knowledge, Skills & Abilities:

· Proficient use of computer software, including Microsoft Office Suite (excel, word)

· Strong organizational skills with the ability to multi-task

· Proficient in HPLC method development and method validation with extensive experience with multiple other analytical techniques and analytical equipment.

· Prior experience and knowledge in FDA GMPs (21 CFR, 211, 820, and/or 600); ISO 9001 and 13485.

Job: *Quality

Organization: *AMRI Burlington

Title: Manager, Quality Control Analytics

Location: MA-Burlington

Requisition ID: 1000867