QA Specialist IV

QA Specialist IV
  • $31.77 - $72.14 per Hour
  • Temporary
  • 20 Pacific Dr. PA, US 20 Pacific Dr. BUCKS US 18951
Job Ref: JO000122349
Sector: Clinical
Sub-sector: Quality
Date Added: 31 August 2021

QA Specialist IV

• Key responsibilities:
o Performs batch record and SOP reviews to ensure cGMP activities are completed and documented in accordance with internal SOPs and regulatory requirements.
o Performs auditing of documentation generated during manufacturing processes and for ancillary areas of manufacturing, coordinating of review and any follow-up action or corrections of GMP documentation.
o Auditing documentation generated from the Quality Control department and the Analytical Laboratory.
o Write/assist with quality related investigations.
o Update current forms into an EPS format.
o Update current SOPs into an EPS and DMS format.
o Maintain accurate records and documentation.
o Upload documentation to DMS and set approval workflows within DMS. Developing ability to interpret and apply cGMP regulations.
o Provide administrative support for metrics management.
o Perform other business critical duties when necessary as determined by management

Key requirements:
o Associates degree or equivalent years of experience working in a GMP industry is preferred.
o Experience in working in the Quality Assurance department in a regulated industry.
o Computer Software skills, record keeping, detail orientated and thorough.
o Experience with TrackWise and Documentum a plus.
o Basic understanding of cGMP regulations and general knowledge of manufacturing processes.
o Shows initiative and is skilled in prioritizing workload in a busy manufacturing environment.
o Ability to work independently.
o Ability to lift up to 30lbs.

SRG is an Equal Opportunity Employer - 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.

30/09/2021 12:00:00
USD 31.77 72.14 Hour
Contact Consultant:
Jennifer Law

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