Quality Assurance Specialist in Burlington, MA

Job Snapshot

Job Description

Description

Quality Assurance Specialist in Burlington, MA AMRI provides global contract research and manufacturing services to the pharmaceutical and biotechnology industries.
The QA Specialist is responsible for maintaining quality databases and providing routine on-the-floor QA presence and oversight to the manufacturing operation. The QA Specialist’s role will include identifying compliance risks in the operation prior to and during execution, avoiding deviation whenever possible as well as managing immediate corrective action.
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 executed/unexecuted batch record review, executed/unexecuted validation/facility protocols/reports, reviewing change controls, and reviewing facility work orders prior to filing
• 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
• Reviews un-executed /executed batch records and quality control testing for compliance with internal SOPs and specifications
• Monitor Operations personnel for adherence to SOP’s. Report back to Manager of QA as well as area functional management as to personnel performance, highlighting those areas and individuals in need of improvement Requirements
• Bachelor’s Degree in life science field; alternate field of study may be considered in combination with significant Aseptic Manufacturing industry experience
• 1+ 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 All interested applicants must apply online. AMRI is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. #LI-AC1

Qualifications

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Job: Quality
Primary Location: Burlington, MA
Schedule: Full time
Job Posting: 04/01/2021
Shift Type:

AMRI is an Equal Opportunity Employer.  All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

If you'd like to view a copy of the company's affirmative action plan or policy statement, please email jobs@amriglobal.com. If you have a disability and you believe you need a reasonable accommodation in order to search for a job opening or to submit an online application, please email jobs@amriglobal.com. This email is created exclusively to assist disabled job seekers whose disability prevents them from being able to apply online. Only messages left for this purpose will be returned. Messages left for other purposes, such as following up on an application or technical issues not related to a disability, will not receive a response.

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