Responsible for performing quality inspections and in-process controls to ensure products meet established specifications, regulatory requirements, and quality standards. This role supports manufacturing operations through effective sampling, inspection, documentation, and timely escalation of quality issues.
Job Responsibilities: (Primary Duties, Roles, and/or Authorities)
Quality Control & In-Process Activities
Perform in-process inspection and sampling activities in accordance with approved procedures, specifications, and sampling plans to ensure product quality and compliance.
Ensure proper handling and traceability of samples throughout the inspection and testing process.
Compliance & Documentation
Ensure strict adherence to Good Documentation Practices (GDP) by maintaining accurate, complete, legible, and contemporaneous records in all quality-related documentation.
Comply and ensure adherence with Good Manufacturing Practices (GMP), company policies, and all applicable regulatory requirements.
Execute all activities in alignment with approved SOPs, Work Instructions, and quality standards.
Deviation Management & Escalation
Identify, document, and escalate non-conformances, abnormal conditions, or deviations in a timely manner using the appropriate quality systems (NCRs(QN s)).
Escalate any condition that does not meet requirements immediately or within defined timelines, ensuring product quality and compliance are not compromised.
Provide real-time feedback to operations to support containment and corrective actions.
Support to Quality Systems
Support investigations by providing accurate data, traceability, and objective evidence related to inspections and sampling.
Maintain quality records.
Support internal/external audits, and audit readiness activities.
Safety & Compliance
Demonstrate compliance with safety programs and contribute to achieving site safety goals.
Maintain required training and certifications, including GMP and safety training.
Adhere to all company policies and procedures.
Perform other duties as assigned to support business needs.
Education and Experience:
Education:
Minimum High School / GED or equivalent.
Experience:
Experience with measurement and inspection equipment.
Knowledge and Skills:
Knowledge of cGMP requirements and regulatory standards.
Understanding of SOPs, Work Instructions, and quality systems.
Strong attention to detail and documentation accuracy.
Ability to identify and escalate quality issues effectively.
Physical Demands: (if applicable)
Required to stand for extended periods of time.
Work Environment: (if applicable)
Manufacturing environment with exposure to production operations, training rooms, and collaboration with cross-functional teams in regulated industries.
Tech 2, Quality Control • El Paso, TX, US
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