QA Senior Associate - External Manufacturing

Team Horizon is seeking an experienced QA Senior Associate for a global biotechnology company. This is primarily a remote role and will provide tactical support activities to Site Leads across multiple Quality Systems and Processes. If you have experience with CMO oversight / external manufacturing, this is the role for you!

Why you should apply:

• Be part of a company who are comitted to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics.


• Role offers the flexibility for remote working (ad hoc travel to site)

What you will be doing:

• Key Responsibilities


• Batch record archivals


• Log LIMS batch


• LIMS sample plan creation/update 


• Enter LIMS data


• Certificate of Analysis creation, as necessary


• Enter SAP master data


• Train on required Quality Systems to perform required tasks


• Escalate risks or roadblocks to management


• Batch disposition activities

• What you need to apply:


• Master’s degree or bachelor’s degree in a Scientific field


• 2+ years of quality and manufacturing experience in biotech or pharmaceutical industry


•  cGMP Experience


• Able to successfully manage workload to timelines


• Familiarity with basic project management tools


• Demonstrated ability to consistently deliver on-time, and high-quality results


• Ability to operate in a matrixed or team environment


• Understanding of the applicable manufacturing/testing processes (i.e. API, Drug Substance, Drug Product, Packaging, Device manufacturing processes