Digital Record Specialist for Pharmaceutical and Medical Devices

hace 2 semanas


Carolina, Carolina, Puerto Rico Flexible & Integrated Technical Services, Llc A tiempo completo

We are Flexible & Integrated Technical Services, LLC, a service provider company that prides itself on treating its resources with care. Our company integrates various services including Engineering, Construction, Maintenance, Utilities, and Specialized Technical services across the island and in the US.

**Job Overview:**

Our team is seeking a Digital Record Specialist to support our Manufacturing area. As a Digital Record Specialist, you will be responsible for converting paper forms and records into electronic formats.

**Key Responsibilities:

* Active participation in IDS/TSMS team meetings to discuss project timelines, activities, escalations, and task statuses.

* Evaluate paper forms, process instructions, and logbooks to create electronic records.

* Assess work centers and equipment capabilities used in production areas.

* Serve as a Subject Matter Expert to assist recipe authors in creating documentation and suggesting improvements.

* Revise and approve configuration documents.

* Participate in triage activities to assess change control requirements and lead/participate in issuing change control requests.

* Review documentation related to PMX production procedures, including core documents and attachments.

* Execute test scripts, identify errors, and correct them. Issue stabilization forms as needed during the transition from paper to electronic records.

* Revise equipment cleaning instructions while transferring them to electronic formats.

**Requirements:**

* Bachelor's degree in Science or Engineering.

* Five years of experience in Quality or Manufacturing within the Pharmaceutical & Medical Devices industry.

* Bilingual: Spanish and English.

* Excellent communication skills and positive attitude.

* Experience in Electronic Batch Record Review, Change Control generation, GMP & GDP regulations.

**Salary:** $85,000 - $115,000 per year based on qualifications and location.

**Benefits:** We offer a flexible, family-oriented work environment, focusing on the well-being of our resources while providing top-notch quality talent to our clients.



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