We are seeking a QA Specialist to support Quality and Manufacturing operations through batch record review, GMP documentation compliance, electronic systems management, inventory control, and quality decision-making. The ideal candidate is detail-oriented, able to work independently in a fast-paced environment, and possesses strong communication, organizational, and problem-solving skills.

Requirements

Education: Doctorate or Masters + 2 years of directly related experience or Bachelors + 4 years of directly related experience.
Perform comprehensive Batch Record Review to ensure completeness, accuracy, compliance, and adherence to approved procedures and GMP requirements.
Experience performing Batch Record Review in a GMP-regulated environment.
Strong knowledge of GMP, GDP, and Data Integrity requirements.
Experience with SAP inventory management and material reconciliation.
Experience using PAX and/or Electronic Batch Record (eBR) systems.
Ability to assess quality/compliance issues and apply risk-based decision making.
Experience participating in manufacturing and quality operations meetings.
Strong organizational skills and ability to manage multiple priorities with minimal supervision.
Fully Bilingual (English & Spanish).

Compétences requises

Batch Record Review (GMP)Knowledge of GMP requirementsKnowledge of GDP requirementsData Integrity complianceSAP inventory managementMaterial reconciliationElectronic Batch Record (eBR) / PAX systemsRisk-based decision makingGMP documentation complianceBilingual English-SpanishCommunicationOrganizational skills and prioritizationProblem-solvingCross-functional collaboration (manufacturing & quality operations)Independent work / Self-management

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