Quality Control Specialist
Company: PTS Advance
Location: San Diego
Posted on: August 7, 2022
PTS Advance is seeking to hire a Quality Control Specialist 2
for one of our clients who are a pharmaceutical manufacturer in San
Deigo, California. As QC Specialist 2 you will act as a Team Lead
and have a strong understanding of products (QC testing,
specifications, QC processes, assay knowledge). You should have a
solid understanding of SQC Trend analysis, Enterprise Resource
Planning, and GMP/GLP requirements.
What you'll do:
- Performs routine testing as needed.
- May lead one or more analysts.
- Designs and executes experiments to troubleshoot
- Generates, performs, and documents laboratory investigations
and non-conformances. Uses standard root cause determination
- Review/analyze data with respect to specifications, validity
criteria, and alert limits.
- Oversees lab maintenance duties. Ensures labs are within a
state of compliance. Performs periodic lab audits.
- Initiates and leads document change control activities. Able to
create/revise QC documents (procedures and specification
- Create and approve CofAs.
- Works closely with QC Scientist on method transfer (NPD).
- Acts as the lead trainer for QC work-cell.
- Performs and documents investigations using standard root cause
- Assists in software & hardware upgrades including executing
- Initiates clear and concise non-conformances. Performs and
documents low severity investigations.
- Monitors trend dashboards for work-cell product lines.
To be successful in this role you will need 6+ years of Quality
experience, preferably in the Life Sciences industry, along with a
bachelor's degree. Intermediate computer skills are necessary.
Keywords: PTS Advance, San Diego , Quality Control Specialist, Other , San Diego, California
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