Quality Control Specialist

Company: PTS Advance
Location: San Diego
Posted on: August 7, 2022

Job Description:

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 non-conformances.
• Generates, performs, and documents laboratory investigations and non-conformances. Uses standard root cause determination methods.
• 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 documents)
• 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 determination methods
• Assists in software & hardware upgrades including executing test protocols.
• 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