Quality Analyst

Flexible & Integrated Technical Services, LLC•Añasco, PR

30d•Onsite

About The Position

This role is for Quality Analyst services within the QS Document Control area. The ideal candidate will possess a Bachelor's Degree and at least one year of previous experience in the Pharmaceutical or Medical Device industry. Bilingual proficiency in English and Spanish is required. The shift is from 11:00 AM to 7:00 PM, with flexibility based on business needs. Experience with GMP and GDP regulations is essential. The role requires a customer-service oriented individual who is innovative and committed to delivering high-quality results.

Requirements

Bachelors Degree
At least one (1) year of previous exposure within the Pharmaceutical or Medical Device industry.
Bilingual: (English and Spanish)
Experience in GMP and GDP regulations.

Nice To Haves

Customer service skills
Innovative mindset

Responsibilities

Record retention activities according to WWRIM policies.
Generating routine reports and metrics related to the change process.
Assisting in the review of quality aspects of submitted change documents for accuracy and consistency.
Proofreading and editing documents for style, grammar, spelling, format, and their impact on other documentation.
Working closely with change originators during change control processes and supporting system tool utilization.
Creating and implementing system processing improvements.
Carrying out quality improvement projects, and other job duties as assigned.
Document and data control business practices, aiming to help reduce change cycle time.
Assisting with internal audits of the change management process.
Supporting process improvement initiatives and ensuring alignment of routine processes and systems to business strategy.
Managing deviations and investigations related to the DCC area.
Facilitating training sessions for the document control area.
Checking change implementation to identify items for closure of completed change orders.