Manufacturing Quality Assurance Specialist

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Basic Job Info

 
Location
US-NY-Melville
 
Degree Required
4 Year Degree
 
Begin Date
9/6/2017
 
End Date
10/5/2017
 
Base Pay
N/A
 
Employment Type
Full-Time
 
Manages Others
False
 
Relocation Covered
False

Job Description

Overview

The candidate for the Manufacturing Quality Assurance Specialist has a robust understanding of applicable regulations and standards and is able to apply company policies, directives, and procedures to ensure compliance by conducting review and approval of quality and production related documentation and procedures in support of internal manufacturing operations. The position advises QA management of compliance issues, conducts quality related activities of diverse scope, and makes decisions and implements associated actions in partnership with the broader team.

Responsibilities

  • Main Responsibilities:

    Act as a quality resource and liaison to operations/manufacturing partners.

    Oversee activities related to cGMP production operations.

    Assist in the development of Standard Operating Procedures, Master batch Record in order to maintain quality systems in line with current regulations, company directives, and industry standards.

    Write and revise Quality Procedures related to production activities.

    Review manufacturing balch records and logbooks.

    Monitor and inspect the production facility during product manufacture and notify QA and manufacturing of potential quality issues.

    Participate in corporate audits and self audits and monitor implementation of CAPAs.

    Carry out assessment of the event, and manage investigation of Deviation, Incident and complaint.

    Participate in training activities to production personnel.

    Monitor the proper implementation of change control for production activities.

    Assist  in preparation of  quality  reports,  such as APR,  and with routine quality KPI reports


Qualifications

Job Requirements

Bachelor's Degree in scientific or technical discipline

Three (3) + years' experience in Quality Assurance operations or systems role, e.g., quality systems (deviation/CAPA, change control), batch record review, auditing

Four (4) +years Pharmaceutical/ Regulated Industry experience

Good organizational skills with high level of attention to detail

Excellent oral and written communication skills with the ability to interact at all levels both internally and externally



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