100,000's of Government Jobs

Search Government Jobs

Job Field: Legal Jobs
Location: San Diego, CA
Salary: $Not stated

JOB SUMMARY:

---

</tr>
<tr><td valign="top" width="450"><b>Position Overview
This position is supporting Operations Technical
Support, responsible for troubleshooting,
optimizing and resolving technical issues in
Operations or any areas needed when directed from
management.  This position is part of a team
supporting and improving the overall product
quality at Alere San Diego.
Organization Chart
Position reports to Director, Operations Technical
Support or Designee
Major Functions Objectives
1.      Spend 80% of time working in the lab
performing the following to support and improve
quality of product and process
      a.     Preparation of materials,
intermediates and reagents
      b.     Perform investigational work
      c.     Perform analysis using different
analytical techniques and instruments
      d.     Process investigation and
optimization
2.      Execute, collect and review data.
3.      Implement and monitor any improvement for
efficacy.
4.      Perform and execute validation where
applicable
5.      Maintain and compile all documentations
i.e. Notebook, DCF, IQ/OQ and PV
Subordinate Objectives
1.      Identify  resolve chemical raw material
and intermediates issues.
2.      Identify  resolve performance issues.
3.      Identify  resolve processes and handling
issues.
4.      Set up and design investigations and
experiments
5.      Record, maintain and summarize all work
done in a timely manner
6.      Objective analysis of data and conclusion
to determine next course of action
7.      Write, plan and execute IQ/OQ and PV
protocols
Management  Organisational Issues
         N/A
Changes  Improvements Necessary
Immediately provide hands-on investigation in
the lab
Provide support for continuous product
improvement both in potential chemistry and
process changes
Increase yield and increase robustness of
process
Problems to be solved
Particle chemistry performance robustness i.e.
Biparticle
Alternative analysis to evaluate and potentially
predict final product performances
Improve reagent performance, and yield
Provide investigational support into process and
parameter
Compliance Skills in actual situation
Understand GMP, quality  compliance crucial
role in all steps leading to the final product.
Perform work in compliance when needed
Technical Skills in actual situation
The candidate will investigate a failed lot of
reagent by evaluating the components used and
review the process parameters.  Propose potential
root cause, and plan experiments to confirm
hypothesis.  He/She would prepare the different
experimental batches of reagents with propose
critical parameters, followed by testing.  The
data will be then reviewed and propose next course
of actions.
Team Skills in Actual Situation
Must be able to demonstrate ability to be part
of a team, and/or multiple teams
Work well with others in a collaborative
environment, and ability to negotiate in situation
where opinion may differ
Show respect
Good communication skill and follow through
Collaborate for IQ/OQ and PV
Long Range Planning, Strategic  Creative
Creative thinking in problem solving
Ability to complete project in timely manner

KEY REQUIREMENTS:

---

None Not stated