Work Schedule

First Shift (Days)

Environmental Conditions

Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

How Will You Make an Impact?

Our team is dynamic and fast paced, relying on teamwork, multitasking, and communication within organization. We are seeking an upbeat individual with strong technical and operational skills to join our team. This position will be responsible to support the Quality Assurance Department responsible for the Quality Management System of the site.

A Day in the Life:

• Revise batch records to ensure compliance with good documentation practices.

• Perform all document-related tasks such as making documents effective, printing, periodic review, withdrawal, reconciliation, issuance, archiving, scanning, record retention, off-site shipment and retrieval, document release, accountability, document audits, etc. with “right the first time” execution as needed.

• Create and revise documents such as SOPs, forms, work instructions and visual aids.

• Manage documents change orders in Oracle (OCPLM).

• Monitor periodic review and effectiveness of the site's documentation.

• Provide training to staff and colleagues.

• Manage the generation of Certificates of Compliance.

• Support change management system as needed

• Participate in other required activities (i.e., perform safety inspections, participate in improvement projects, other documentation processes, etc.) and cross-functional activities.

• Participate in shift exchanges, 1-1’s, meetings and team building exercises.

• Participate in internal and external audits as required.

Education:

• High school diploma or equivelent

Experience:

• One year of experience is preferred.

• Previous experience in regulated environment with knowledge of good manufacturing and documentation practices is an asset

Knowledge, Skills, Abilities:

• Bilingual (Spanish / English)

• Computer literate, proficiency in Microsoft Word, Excel and Power Point.

• Following standard operating procedures (SOPs)

• High ethical standards – will not compromise quality requirements.

What We Offer

Compensation

• Competitive Hourly Pay Rate

• Annual performance-based bonus

• Annual merit performance-based increase

Excellent Benefits

• Benefits & Total Rewards | Thermo Fisher Scientific

• Medical, Dental, & Vision benefits-effective Day 1

• Paid Time Off & Designated Paid Holidays

• 401K

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.