Investigation & Client Quality Specialist

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/78rpnm

Overview Experteer Overview In this role, you ensure product quality and regulatory compliance within a GMP environment, enabling scientific teams to perform breakthrough work. You'll support continuous improvement and collaborate with cross?functional partners to uphold high quality standards. The position combines audit activity, documentation review, and issue resolution to drive reliable, compliant operations. This is a mission?driven opportunity to contribute to safer, healthier outcomes at scale. You will engage with audits, CAPA processes, and quality investigations to shape robust quality systems.
Responsibilities Ensure product quality and regulatory compliance in a GMP environment
Drive continuous improvement initiatives and support quality initiatives across functions
Collaborate with cross?functional teams to maintain high standards of quality and compliance
Perform internal quality audits and support external regulatory audits
Review batch records, SOPs, deviations and CAPA documentation
Conduct quality investigations and root cause analyses
Maintain and utilize quality management systems and documentation
Prepare and analyze documentation for audits and compliance




Proactively identify quality risks and implement mitigation plans
Utilize computer tools (TrackWise, SAP) and MS Office to manage records
Qualifications Bachelor's degree
Experience in pharmaceutical, medical device or regulated industry preferred
Strong knowledge of cGMP, ISO **********, and international regulatory requirements
Experience with quality systems and documentation (batch records, SOPs, deviations, CAPA)
Proficiency with quality management software (TrackWise, SAP)
Ability to perform detailed documentation reviews and quality assessments
Strong analytical and problem?solving skills for investigations and root cause analysis
Excellent written and verbal communication skills
Ability to work independently and in cross?functional teams
Experience with internal quality audits and supporting external regulatory audits
Proficient in Microsoft Office
Good attention to detail and accuracy
Ability to prioritize and adapt in a changing environment
Lean and Six Sigma experience preferred
May require up to 10% travel
Must be able to work in controlled environments wearing PPE
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Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/78rpnm