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Safety and Regulatory Quality Control

1 month ago

Collegeville, United States Aequor Full time

Position: Safety and Regulatory Quality Control (Packaging & Labeling Artwork Change Contractor) 32103-1

Location: Collegeville PA 19426 OR Lake Forest, Illinois

Duration: 18 Months (possibility to extend)

Pay rate: $54.94/ hour on W2


  • Hard Skill:
  • Document management system - Electronic Artwork and Labeling Management System
  • Word, Excel
  • Proof Reading System Knowledge - Nice to have
  • Artwork and Labeling Familiarity
  • FDA Labeling/packaging regulations familiarity
  • Regulatory Strategy or QA labeling/packaging BG - Preferred
  • Pharm Packing BG - Nice to Have
  • Data Management/System familiarity is a plus.

The job title for this request is Packaging & Labeling Artwork Change Contractor.


This is a project management and troubleshooting role that liaises between local client Markets and relevant Manufacturing Plants or Artwork Centers (AWCs) to assure timely implementation of artwork for labeling on packaging components according to local Regulatory Agency requirements.


This role coordinates Artwork Change Control workflows for assigned products, markets, and, vendors in client’s electronic Packaging Artwork and Labeling System (ePALMS). In some cases, this role also negotiates Artwork Implementation requirements across clusters of markets with conflicting requirements and may sometimes work across regions.


Incumbent actively engages with key Packaging and Labeling Artwork stakeholders in Global Regulatory Affairs (GRA), Global Labeling Management (GLM), International Labeling Group (ILG), client Global Supply (PGS) plants as well as relevant PGS Demand Management functions. They often take the lead in negotiating Regulatory timelines for Artwork Implementation on Product Labeling and associated packaging components, taking into account conflicting drivers across markets and/or stakeholders to ensure Regulatory requirements are met and product supply is not impacted.


Colleague fundamentally performs the ePALMS system “Market Coordinator” (MC) role in close collaboration with the Global Regulatory Affairs (GRA) Strategy functions at client Country Offices (PCOs) and is the central Regulatory point of contact for the PGS plants/Artwork Centers (AWC). Colleague operates from a subject matter expert (SME) centralized “hub” capacity and in some cases, may perform Regulatory Strategist roles & responsibilities where specific tasks are delegated and in line with local and global SOPs/Work Instructions.


Responsibilities include:

Initiation and “build” of client Artwork Requests (PARs) using an electronic artwork change management system in collaboration with local markets (PCOs), assuring all

required information, specifications and/or supportive documentation is available for plants/AWCs to execute the production of product Labeling related packaging components.

Negotiating Artwork Change Control logistics across multiple Pfizer departments (as well as multiple markets) to ensure Regulatory timelines for Implementation are met and that product supply is not interrupted


Liaises with markets and stakeholders to gather all necessary information to initiate and “build” PARs (according to local or regional requirements) to enable plant production of Labeling Artwork with minimal rework and to meet Implementation requirements.

Create Editor’s Copy (EC) for select markets depending on the language(s) involved and specific “custom” services negotiated with markets in line with SOPs.


Upon receipt of final draft Artwork, reviews proofreading report and resolves any technical formatting questions or errors; assures necessary proofreading of final printed Artwork against EC is completed using appropriate tools; escalates any issues, questions, or errors within ALIM functional line or appropriate markets for adjudication as needed.