Quality Assurance

eg

CARLOS E. MORENO, JR.

******.*.********@*****.*** 323-***-**** SOUTH GATE,

CA 90280

OBJECTIVE Results-driven Quality Assurance professional with 7+ years of experience

ensuring regulatory compliance in the plasma industry. Expertise in GMP,

deviation management, and audit preparation. Seeking a Quality Assurance,

Compliance, or Auditing role where I can apply my analytical skills and

regulatory knowledge to drive operational excellence.

SKILLS & * Regulatory Compliance (GMP, FDA, SOP Adherence)

ABILITIES * Deviation & CAPA Management

* Audit & Inspection Readiness

* Document Control & Record Review

* Training & Process Improvement

* Quality Oversight & Risk Assessment

* Bilingual: Spanish & English

EXPERIENC OCTAPHARMA PLASMA INC. - QUALITY ASSURANCE TECHNICIAN

E September 2017 to October 2024

* Oversaw daily quality operations, ensuring full compliance with SOPs, cGMP regulations,

and FDA requirements through proactive quality oversight.

* Independently reviewed and approved manufacturing records, equipment calibration logs,

and donor files, mitigating compliance risks before escalation.

* Provided direct guidance to center management, identifying quality gaps, recommending

corrective actions, and ensuring timely implementation.

* Led internal audits and self-assessments, driving continuous improvement initiatives and

reducing non-conformances by implementing preventive measures.

* Served as a key trainer and mentor to staff on quality procedures, ensuring alignment with

regulatory expectations and fostering a culture of compliance.

* Executed final QA review and release of products and shipments, ensuring documentation

accuracy and adherence to quality standards.

* Prepared and co-hosted audits, collaborating with leadership to address findings, implement

corrective actions, and sustain compliance.

* Analyzed quality trends and deviations, working with cross-functional teams to strengthen

quality processes and regulatory compliance.

* Acted as the primary QA liaison between quality and operations, ensuring alignment

between production needs and compliance requirements.

* Assisted in training new Quality Assurance Employees, reinforcing company standards and

best practices.

* Identified and mitigated compliance risks by proactively monitoring deviations, trends, and

recurring issues to prevent regulatory violations.

SUNNYSIDE LLC. — Handling Operator

January 2016 to August 2017

* Managed inventory tracking and reconciliation, ensuring 99% order accuracy in

shipping/receiving.

* Optimized warehouse logistics by implementing an improved inventory system, reducing

stock discrepancies.

Michaels Arts & Crafts — Sales Associate / Team Manager

September 2012 to January 2016

* Provided customer service & team leadership, training new hires on store procedures and

product knowledge.

* Managed cash handling and inventory tracking, ensuring accurate sales reconciliation.

BACKSTAGE WEB INC. —- SHIFT LEAD, WAREHOUSE RECEIVING

February 2007 to August 2012

* Supervised high-volume order fulfillment & quality checks, ensuring timely

and accurate shipments.

* Conducted weekly inventory audits to maintain stock accuracy and

minimize discrepancies

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