QA Specialist Packaging

QA Specialist Packaging
  • Competitive
  • Temporary
  • Philadelphia PA, US Philadelphia PHILADELPHIA US 19114
Job Ref: JO000127094
Sector: Clinical
Sub-sector: Quality
Date Added: 31 December 2021

.This role provide real time Quality oversight during the packaging operations of LAIV production. The QA OTF Associate roles ensure that operations are executed in accordance with cGMPs; makes real time decisions on GDP, GMP and quality compliance issues and possesses knowledge of both US and international regulatory guidelines and standards

Role and Responsibilities

• Provide QA oversight of aseptic processing including QA audit program

• Execute personnel monitoring within the aseptic processing area using MODA system

• Execute AQL sampling and inspection of finished drug product

• Conduct real time review of batch records, logbooks, and other associated GMP documents

• Assist quality investigations related to deviations and environmental monitoring excursions

• Accountable for maintaining training compliance including training seasonal staff

• Support additional site and quality functions, including but not limited to:
o Change Control

o SOP creation and revision

o Validation documentation review

o Site Wide Projects o Trend reporting

Skills and Experience

• Possesses strong computer skills and familiarity with quality systems such as TrackWise

• Experience with aseptic techniques

Desirable -

Candidate - Demonstrates ability to work independently and within a team environment

• Excellent written / verbal skills / Interpersonal skills


Bachelor of Science in Biology, Chemistry, Engineering, or related fields


All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.

30/01/2022 12:00:00
USD 0.00 0.00 Hour
Contact Consultant:
Jennifer Law

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