November 4, 2024

Juana Díaz

FULL TIME

Main Functions / Responsibilities:

Education and Experience Requirements:

Bachelor's degree in Sciences or Engineering
and 3-5 years of directly related experience years of directly related experience.

Preferred Qualifications:

Expertise in Quality Systems such as Deviations (Non-conformities, CAPA, and Change Control).
Hands-on experience in electronic systems for instance: Documentation platforms (CDOCS), Maximo, Trackwise, LIMS, electronic batch record (MES) and SAP.
Experience with Validation of Gx P applications, Validation Master Plan, Installation Qualification (IQ), Risk Assessment/Gx P assessment, Operational Qualification (OQ), and Performance Qualification (PQ) Protocols, Test Scripts, and Completion/Summary Reports approvals as per the compliance requirements.
Strong communication (both written and oral), facilitation and presentation skills. Bilingual in English and Spanish.

Skills:

Project management skills.
Strong organizational skills, including ability to follow assignments through to completion.
Initiate and lead cross functional teams.
Enhanced skills in leading, influencing and negotiating.
Strong knowledge in area of expertise.
Collaborate and coordinate with higher level outside resources.
Strong knowledge of and experience with processes involved in manufacturing and distribution, QA, QAL, validation and process development.
Demonstrate ability to interact with regulatory agencies.
Strong word processing, presentation, database and spreadsheet application skills.
Strong communication (both written and oral), facilitation and presentation skills.
Strong skill in working independently and to effectively interact with various levels.
Advanced data trending and evaluation.
Ability to evaluate compliance issues.

Work Methodology:

Full time project opportunity
Administrative shift Monday to Friday from 8am to 5pm (requires availability to work overtime or non-regular hours during special project activities)
100% on-site job
2 years of expected project duration
Professional services agreement