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Laboratory Investigation Scientist-Parenteral
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The Laboratory Investigations Scientist is responsible for conducting, documenting, and supporting investigations related to deviations, out-of-specification (OOS) results, and non-conformances associated with the testing and manufacturing of parenteral (sterile injectable) products. This role ensures compliance with cGMP regulations while supporting root cause analysis and implementing corrective and preventive actions (CAPA). Key Responsibilities: Lead and support laboratory investigations for OOS, OOT (Out of Trend), deviations, and atypical results related to parenteral products. Perform root cause analysis using structured methodologies (e.g., fishbone diagrams, 5 Whys). Review analytical data, laboratory documentation, and manufacturing records to identify discrepancies. Collaborate with Quality Assurance, Manufacturing, Microbiology, and Analytical teams to support investigations.

Requisitos:
 Requirements:
 Bachelor’s degree in Chemistry, Biology, Microbiology, Pharmaceutical Sciences, or related field (Master’s preferred). Minimum of 2–5 years of experience in a pharmaceutical laboratory, preferably in sterile or parenteral manufacturing environments. Strong knowledge of cGMP regulations and FDA guidelines. Proven experience handling OOS, deviations, and laboratory investigations. Strong analytical thinking and problem-solving skills. Bilingual (Spanish/English) Ability to work cross-functionally and manage multiple priorities.

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Empleos en Puerto RicoJobs in Puerto Rico
QRC GROUP LLC

Empleos en Puerto RicoJobs in Puerto Rico Profesionales
Caguas PR 00600 Caguas
DescripciónDescription The Laboratory Investigations Scientist is responsible for conducting, documenting, and supporting investigations related to deviations, out-of-specification (OOS) results, and non-conformances associated with the testing and manufacturing of parenteral (sterile injectable) products. This role ensures compliance with cGMP regulations while supporting root cause analysis and implementing corrective and preventive actions (CAPA). Key Responsibilities: Lead and support laboratory investigations for OOS, OOT (Out of Trend), deviations, and atypical results related to parenteral products. Perform root cause analysis using structured methodologies (e.g., fishbone diagrams, 5 Whys). Review analytical data, laboratory documentation, and manufacturing records to identify discrepancies. Collaborate with Quality Assurance, Manufacturing, Microbiology, and Analytical teams to support investigations. Requisitos Requirements Bachelor’s degree in Chemistry, Biology, Microbiology, Pharmaceutical Sciences, or related field (Master’s preferred). Minimum of 2–5 years of experience in a pharmaceutical laboratory, preferably in sterile or parenteral manufacturing environments. Strong knowledge of cGMP regulations and FDA guidelines. Proven experience handling OOS, deviations, and laboratory investigations. Strong analytical thinking and problem-solving skills. Bilingual (Spanish/English) Ability to work cross-functionally and manage multiple priorities.
Requiere Mucha Experiencia Requires Expert
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Los patronos NO le piden dinero ni un depósito para trabajar, si lo piden es un negocio, inversión o Fraude.
NO envíe dinero para trabajar, tampoco ofrezca información personal, por teléfono o email. Evite el Fraude ClasificadosOnline Warning
Employers DON'T ask for money or deposits for work, if they do is a bussiness, invertion or Fraud.
DON'T send money for work, neither offer personal information, by phone or email. Avoid the Fraud

Empleos en Puerto RicoJobs in Puerto Rico
QRC GROUP LLC

Empleos en Puerto RicoJobs in Puerto Rico Profesionales
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