Quality Investigations Specialist in Burlington, MA at AMRI

Date Posted: 4/7/2020

Job Snapshot

Job Description

Description

QualityInvestigations Specialist in Burlington, MA

AMRI provides global contract research and manufacturingservices to the pharmaceutical and biotechnology industries.


The Quality InvestigationsSpecialist will work within the Quality Assurance team in collaboration withother departments to conduct deviation investigations, root cause analysis, andsupport corrective actions. Thisindividual will assist with ensuring compliance with cGMPs, company, customerand regulatory quality standards according to requirements.  Specifically, this individual will beresponsible for writing, reviewing, and/or approving investigations to ensurecompliance with established standards. The quality systems investigations includebut are not limited to, deviations, customer complaints, COTs, EM-viable, EMnon-viable and OOS.

Join our talentedworkforce, where a commitment to excellence and a customer focused attitude iseverything. We pursue excellence because our work has the power to improvepatients’ lives with the pharmaceuticals we develop and manufacture.

Responsibilities


Participate in thedeviation, change control, complaint handling, and CAPA systems at thesite.  This entails ensuring that theprocesses, their respective procedures and their use meet current regulatoryexpectations and industry best practice.

•         Participateand/or lead investigation teams to ensure all events are thoroughly documentedand the appropriate CAPAs are identified


•         Useappropriate tools to compile, track, trend, analyze and report key performanceindicators and metrics in order to identify areas of non-compliance, bestpractice and improvement opportunities


•         Prepareinformation related to the state of the QMS to be used in routine monthlyreporting and Quality Council meetings


•         Proactively,based on data analysis, recommend to management areas of improvement within thevarious operations


      Participate in self-development activities to stay current with regulatory expectations and industry best practices in quality systems investigations


      Exhibit safety awareness and safe work practices


Qualifications

Requirements

 

Bachelor’s Degree in related field required


2 years of experience with quality assuranceinvestigations in the Pharmaceutical industry


Must have demonstrated ability to workindependently and as part of a team 


Able to organize and write complextechnical documents


Ability to write clear, concise,complex reports, assessments and documents


Excellent written and verbalcommunication skills

All interestedapplicants must apply online. AMRI is anEqual Opportunity Employer, we value diversity and inclusiveness.  Minorities/females/veterans/individuals withdisabilities/sexual orientation/gender identity are encouraged to apply.



Albany Molecular Research, Inc. is committed to providing equal opportunity to all job seekers including qualified individuals with disabilities. If you have any difficulty using our online application system due to a disability or believe you need a reasonable accommodation to search for a job opening or submit an application, you may use the alternative email address jobs@amriglobal.com to contact us about your interest in employment or you may call us at 518.512.2000. Please note: The above-referred email address and telephone number are dedicated communication lines designed exclusively to assist job seekers whose disability prevents them from being able to apply online. Messages left for other purposes will not receive a response.

Job: Quality
Primary Location: US-MA-Burlington
Other Locations:
Organization: AMRI Burlington
Schedule: Full-time
Job Posting: Feb 12, 2020, 9:23:31 AM
Shift Type: Standard 8

AMRI is committed to providing equal opportunity to all job seekers including qualified individuals with disabilities. If you have any difficulty using our online application system due to a disability or believe you need a reasonable accommodation to search for a job opening or submit an application, you may use the alternative email address jobs@amriglobal.com to contact us about your interest in employment or you may call us at 518.512.2000.

Please note: The above referenced email address and telephone number are dedicated communication lines designed exclusively to assist job seekers whose disability prevents them from being able to apply online. Messages left for other purposes will not receive a response.