Automation, Biology, Change Control, Corrective and Preventative Action (CAPA) Systems, Environmental Work, Incident Management, Manufacturing/Industrial Processes, Process Validation, Product Reviews, Product/Service Launch, Quality Assurance, Regulatory Compliance, Risk Analysis, Secondary School, Validation Plan
Inteldot has over 15 years in the life sciences industry, with operations across Puerto Rico, the United States, Europe, and Japan. This is a great opportunity for one of our leading clients in Puerto Rico.
Administrative Shift
Job Description:
Under minimal supervision, support Quality Assurance program by performing a variety of key responsibilities in manufacturing, process validation, regulatory compliance, and quality assurance activities.
Requirements:
- NPI, Change Control, FATs, Validation, and PPQ
Preferred Qualifications:
- Review and approve product MPs.
- Approve process validation protocols and reports for manufacturing processes.
- Request Quality on incident triage team.
- Approve Environmental Characterization reports.
- Release of sanitary utility systems.
- Approve planned incidents.
- Represent QA on NPI team.
- Lead investigations.
- Lead site audits.
- Own site quality program procedures.
- Designee for QA manager on local CCRB.
- Review Risk Assessments.
- Support Automation activities.
- Support facilities and environmental programs.
- Approve NC investigations and CAPA records.
- Approve change controls.
- Experience with key electronic systems, such as documentation platforms (e.g., CDOCS), Maximo, TrackWise, LIMS, MES/electronic batch record systems, and SAP.
Education
- Educational background in Life Sciences and/or Engineering.
- Masters + 2 years of directly related experience or Bachelors + 4 years of directly related experience or Associates + 8 years of directly related experience or High school/GED + 10 years of directly related experience.