Quality Investigations Specialist in Burlington, MA at AMRI

Date Posted: 12/4/2019

Job Snapshot

Job Description

Quality Investigations Specialist in Burlington, MA

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


The Quality Investigations Specialist will work within the Quality Assurance team in collaboration with other departments to conduct deviation investigations, root cause analysis, and support corrective actions. This individual will assist with ensuring compliance with cGMPs, company, customer and regulatory quality standards according to requirements.  Specifically, this individual will be responsible for writing, reviewing, and/or approving investigations to ensure compliance with established standards. The quality systems investigations include but are not limited to, deviations, customer complaints, COTs, EM-viable, EM non-viable and OOS.

Join our talented workforce, where a commitment to excellence and a customer focused attitude is everything. We pursue excellence because our work has the power to improve patients’ lives with the pharmaceuticals we develop and manufacture.

Responsibilities


Participate in the deviation, change control, complaint handling, and CAPA systems at the site.  This entails ensuring that the processes, their respective procedures and their use meet current regulatory expectations and industry best practice.

•         Participate and/or lead investigation teams to ensure all events are thoroughly documented and the appropriate CAPAs are identified


•         Use appropriate tools to compile, track, trend, analyze and report key performance indicators and metrics in order to identify areas of non-compliance, best practice and improvement opportunities


•         Prepare information related to the state of the QMS to be used in routine monthly reporting and Quality Council meetings


•         Proactively, based on data analysis, recommend to management areas of improvement within the various 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

Job Requirements

Requirements

 

Bachelor’s Degree in related field required


2 years of experience in a quality assurance and/or regulatory experience in the Pharmaceutical industry, OR 5 years of experience in Pharmaceutical industry with demonstrated understanding of laboratory, manufacturing, packaging, regulatory, compliance, and quality assurance requirements for biological and drug product manufacturing


Must have demonstrated ability to work independently and as part of a team 


Able to organize and write complex technical documents


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


Excellent written and verbal communication skills


Ability to facilitate multifunctional meetings

All interested applicants must apply online. AMRI is an Equal Opportunity Employer, we value diversity and inclusiveness.  Minorities/females/veterans/individuals with disabilities/sexual orientation/gender identity are encouraged to apply.



Shift:  Standard 8

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.

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.