Job Details

  • Title: QA Specialist
  • Code: RCI-PFE-16112-1
  • Location: Andover Massachusetts (MA) 01810
  • Posted Date: 07/09/2019
  • Duration: 12 Months
  • Status: Open
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  Job Description

This position reviews and approves documentation associated with the supply, receipt, testing, and release of raw materials and cell banks used in clinical and commercial manufacturing to ensure timely review and disposition of batches/lots. Accountable for activities involved in the evaluation process of related documents to determine if product specifications are met, ensuring that established sampling and statistical process control procedures are followed, identifying and reviewing deviations from established standards in the manufacturing and/or packaging of products, and reviewing and approving investigations and change control activities to ensure compliance.

  • Leads and/or supports the investigation to resolve routine quality issues related to Raw Materials identified through supplier notifications, site scheduling needs and material issues
  • Provides support for site initiatives for the launch of new products and maintain inspection-ready, cGMP compliant supplier and material files
  • Responsible for activities related to setting and maintaining quality standards aligned with US FDA cGMP and other applicable international and guidances
  • Represents the QA function on various cross-functional Teams and initiatives
  • Performs all work in compliance with cGMPs and site requirements
  • Review and approval of GMP documentation and their compliance to Client's Quality Standards
  • Ensure adherence to quality procedures, regulatory requirements, and cGMPs
  • Skilled at the use of Enterprise systems including, but not limited to site Quality Tracking System (QTS), Laboratory Information Management System (LIMS), SAP and client's document repositories
  • Review and approval of deviations and resulting investigation reports, corrective actions and/or preventive actions for adequacy, logic and quality/validation/regulatory impact
  • Author, review and edit documents as required such as annual product reviews and certification documents. Actively participate in investigations and compliance related issues
  • Ability to interpret and document information according to standard operating procedures using all standard Quality systems
  • Excellent oral/written communication and presentation skills
  • Has received training in cGMP, relevant regulatory guidelines, and procedures. Working knowledge with database and/or electronic document management systems required (Microsoft Word, Excel) and familiarity with other software a plus (Microsoft Project, Access, etc.)
  • Ability to interpret and document information according to standard operating procedures using all standard Quality systems
  • Strong Technical Writing and Background
  • Strong communication skills with peers and management
  • Ability to handle complex and detailed issues
  • Primarily an Office position. Most likely this position will not be in the production area, warehouse or laboratory
  • Bachelor of Science Degree in Microbiology, Biology, Chemistry or related Technical Physical Science
  • Minimum of five years’ experience in GMP Pharmaceutical Manufacturing environment. Previous experience in Quality Assurance or Quality Control preferred