Document Control Specialist

United States, Quakertown (Pennsylvania)

Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

Lonza is actively seeking a Document Control Specialist for our Quakertown, PA location. The Document Control Specialist is responsible for technical administration activities within the Quality Assurance (QA) department. This position reports to the Compliance Manager and is responsible for all the upkeep, maintenance and control of all QA related documents. Such documents include SOP's, forms, regulatory documents etc. They will operate in line with GMP and customer requirements in respect to compliance, timing, accuracy and availability of information.

Key responsibilities:

  • Active support of Document Management System (DMS). Assists in document lifecycle through creation, editing, review, issuing and archiving in respect of batch records, SOPs and quality system records.
  • Issue Batch Records and Master Production Records from DMS to the production line.
  • Writes SOPs and manages templates with support from specialist colleagues
  • Responsible for: initiation, investigation and completion of Minor process deviations aimed at identification of
  • root cause, and implementation of correct actions to prevent recurrence.
  • Identifies compliance/non-compliance with procedures and resolves necessary amendments to GMP documentation
  • Running database queries and reports in addition to data entry
  • Prepares data for customer audits and regulatory inspections
  • May train new staff in use of quality systems
  • Review completed Batch Records
  • Administrative support for deviation management, action plans (CAPAs) and change requests
  • Developing ability to interpret and apply cGMP regulations
  • Provide administrative support for metrics management
  • Perform other business critical duties when necessary as determined by management

Key requirements:

  • Associates degree required. Bachelor’s degree or equivalent years of experience in technical area preferred.
  • Experience in working in the Quality Assurance department.
  • Computer Software skills, record keeping, detail orientated and thorough.
  • Experience with Trackwise and Documentum a plus.
  • Basic understanding of cGMP regulations and general knowledge of manufacturing processes
  • Shows initiative and is skilled in prioritizing workload in a busy manufacturing environment.
  •  Ability to work independently.
  • Ability to lift up to 30lbs.
Reference: R32049