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