Document Controller

2 weeks ago

Potters Bar, Hertfordshire, United Kingdom Ascend Gene & Cell Therapies Full time

Title:
Quality Assurance Document Controller (Temporary Fixed Term contract)

Reporting to:
Quality Assurance Manager

Location:
North London, South Mimms Facility

About Ascend:

Ascend strive to improve on what's gone before, creating therapies that change lives. We focus on constantly refining and flexing our approach and embracing opportunities to innovate.


Through a series of acquisitions, we have carved out an array of CMC units, and brought in experienced biotech specialists to offer their skills as a service.

With origins in biopharma, our expert teams have "been there and done that" with regulators. We understand the quality and potency of manufacturing high-class products is just as important as the yield.


We have GMP headquarters in the UK, state-of-the-art product development and innovation facilities in Munich as well as a team of innovative scientists in the San Francisco Bay Area, California.


Why we're different:


Are you looking to disrupt the industry and develop in an interdisciplinary creative space whilst pursuing your passion in gene and cell therapy? We're building a place for people who want to make a difference and aim higher.

Inspired by the possibilities of biological engineering for gene & cell therapy technologies. We want to lift and inspire the new generation of experts and breakthrough start-ups. Our start-up mindset and knowledge have enabled rapid growth and success and we don't plan to stop here. There are no limits and there's no stopping us.

The Role:

Main Responsibilities:

  • Supporting the QA team in updating and managing Quality documentation.
  • Review and progression of high volumes of electronic documentation
  • Document quality checking (for compliance with templates and formatting) prior to QA check and loading on to the documentation system.
  • Scanning of hard copy documentation.
  • Archiving activities, including filing and maintenance of records (electronic and paper)
  • Printing and collation of controlled copies (Logbooks, batch records, test methods etc.)

Requirements:

  • Understanding of Good documentation practices and ALCOA+
  • Understanding of controlled (documentation)
  • Ability to manage priorities in alignment with department objectives.
  • Strong Team player
  • Ability to work in a fastpaced environment and to prioritise own work.
  • Good Written & Oral Communication skills.

Benefits
As well as a competitive salary, fantastic professional development opportunities and career progression we offer:

  • Performance based bonus
  • Pension scheme
  • Share scheme
  • More to come as we grow

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