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Contract Quality Systems Manager

Franklin Ctr, PA 19341

Posted: 11/27/2024 Employment Type: Contract Job Category: Quality and Compliance Job Number: 612857 Is job remote?: No Country: United States

Job Description


Target Pay Rate: 45-58.66/hr **salary will be commensurate with experience 

Job Description:


This position is responsible for maintaining and improving Quality Systems for the Americas Region to ensure on-going compliance to applicable compendia, GMPs, and Regulatory guidance. The Quality Systems include quality risk management, documentation, global and local auditing, health authority inspection management, training, event management (deviations, complaints, CAPA), and change control (global and local). The role will interface with Quality System personnel in other sites.

The person in this position will serve as a subject matter expert (SME) for GMP and Data Integrity (DI) requirements. Must effectively work as a team with internal customers, peers, and management through effective oral and written communication. Must evaluate the compliance of records, documents, and Quality Systems to ensure that the site is operating per GMP and Data Integrity requirements.

Essential Functions
  • Collaborate and provide expert reviews to ensure records, documents, and Quality Systems meet GMP and DI requirements (promote quality, DI, and GMP awareness).
  • Support external and internal audits for the Americas sites.
  • Contribute to the oversight of Quality Systems core responsibilities (track, report, adjust) by trending quality metrics for Americas sites.
  • Develop and manage processes that ensure the Exton site remains in compliance with global quality polices, regulatory requirements, and industry requirements, including periodic review and consolidation.

Other duties as assigned to facilitate ongoing Quality activities as required, including collaboration with other Quality groups.

Requirements Education and Experience
  • Bachelors degree (preferably in science related discipline) preferred
  • 5 - 7 years of experience working with Quality Systems (Deviation, Change Control, CAPA, audit, etc.)
  • Demonstrated proficiency and experience in working with Quality Systems IT applications
  • Training within a regulated Pharmaceutical/biotech/medical device environment
  • Understanding and application of CGMPs (EU, JP, US)
  • Detailed knowledge and application with electronic Quality Systems (i.e. TrackWise, Documentum)

Technical
  • Strong attention to detail as demonstrated through consistent quality of work
  • Excellent written and verbal communication skills
  • Computer proficiency in MS Word and Excel, Project and Visio required;
  • Demonstrates process orientation-thinks through required steps and sequencing to ensure quality work output
  • Strong project management skills are preferred
  • Ability to anticipate potential problems and take proactive action to avoid/minimize impact
  • Anticipates consequences of actions and how they impact other areas
  • Ability to independently prioritize, plan and schedule workflow
  • Timely follow up to ensure satisfactory resolution to issues
  • Knowledge of CGMPs (relevant laws, guidance, directives and industry practice), and demonstrated ability to apply learnings appropriately
  • Ability to interpret and apply GMPs, relevant laws, guidances and directives to extremely complex pharmaceutical situations
  • Ability to work and coordinate activities across multiple functional groups with a sense of professionalism and urgency
  • Ability to work collaboratively with internal and external team members and customers/contacts
  • Self-motivated; able to work with minimal supervision. Exercises independent judgment in evaluating compliance.
  • Ability to work in a controlled environment
  • Good attendance and reliability
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About Franklin Ctr, PA

Ready to take the first step towards a fulfilling career in Franklin Center, Pennsylvania? This vibrant area, nestled in the heart of beautiful Bucks County, offers job seekers a unique blend of opportunities for growth and success. From its close proximity to iconic attractions like the historic Fonthill Castle and the bustling Peddler's Village, to its thriving arts scene featuring the James A. Michener Art Museum and the Bucks County Playhouse, Franklin Center is a hub of culture and charm. With delectable local cuisine, picturesque parks like Peace Valley Park for outdoor enthusiasts, and easy access to Philadelphia's professional sports teams and renowned venues, this region promises an enriching career experience like no other. Explore our job listings now and discover the endless possibilities waiting for you in Franklin Center, Pennsylvania!

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