QA Senior Associate

1 day ago


Dublin, Ireland Team Horizon Full time

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 committed 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:

1. Batch record archivals
2. Log LIMS batch
3. LIMS sample plan creation/update
4. Enter LIMS data
5. Certificate of Analysis creation, as necessary
6. Enter SAP master data
7. Train on required Quality Systems to perform required tasks
8. Escalate risks or roadblocks to management
9. Batch disposition activities

What you need to apply:

1. Master’s degree or bachelor’s degree in a Scientific field
2. 2+ years of quality and manufacturing experience in biotech or pharmaceutical industry
3. cGMP Experience
4. Able to successfully manage workload to timelines
5. Familiarity with basic project management tools
6. Demonstrated ability to consistently deliver on-time, and high-quality results
7. Ability to operate in a matrixed or team environment
8. Understanding of the applicable manufacturing/testing processes (i.e. API, Drug Substance, Drug Product, Packaging, Device manufacturing processes)

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