Sr. Quality Assurance Specialist in Burlington, MA at AMRI

Date Posted: 5/6/2020

Job Snapshot

Job Description

Description
AMRI provides global contract research and manufacturing services to the pharmaceutical and biotechnology industries.
 The Senior Quality Assurance Specialist is an integral part of the AMRI Quality team, contributing to our success by providing quality oversight for client specific site validation programs, quality assessment of validation and quality investigations,  providing routine on-the-floor QA presence for client specific processes, training manufacturing quality personnel for on the floor oversight, driving on time batch record reviews, and oversight to the manufacturing operation.
 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

•Responsible for working cross-functionally with Manufacturing, Process Engineering, Facilities, Inspection, and Project Management on Quality Assurance (QA) activities such as the following:
oQuality oversight for validation (review of IQ, OQ & PQ packages)
oCompliance to Validation Master Plan requirements 
oManufacturing Quality Oversight (batch record review, quality approver for manufacturing deviations)
oQuality Impact Assessment for Manufacturing and validation related Deviations, Change Controls, and CAPA
oDriving Quality Metrics 
oProduct Disposition 
•Educate and train manufacturing/process engineering personnel to execute production in full accordance with cGMP’s and AMRI’s quality system to ensure real-time compliance
•Represent AMRI quality assurance when managing issues that require immediate corrective action. Ensure such action taken is appropriate and appropriately documented

Qualifications
•Bachelor’s Degree in life science field; alternate field of study may be considered in combination with significant Aseptic Manufacturing industry experience
•6 years of experience in Quality Assurance supporting manufacturing in Pharmaceutical, Biotechnology or Medical Device industry
•Previous experience supporting on-the-floor activities for production facility
•Strong facilitation and problem solving skills
•Excellent written and verbal communication and presentation skills. Comfortable presenting information to management & peers
•Comfortable working independently in combination with individuals in other departments across the organization
•Strong working knowledge of PDA, FDA (21 CFR Part 210, 211, 600), EMA (Eudralex Volume 4), ICH, ISPE, USP/EP monographs, and GAMP 5 guidance
•Proficient in Microsoft Office and TrackWise

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.
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: May 10, 2020, 1:09:49 PM
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.