Sr Specialist Tech Engineering

QRC Group; Juncos (PR); On-site; USD 90,000 - 130,000; Full time

Job summary

QRC Group in Juncos, Puerto Rico seeks a Facilities and Engineering Support Specialist to maintain the integrity and compliance of the manufacturing facility. You will support Quality Systems, including deviations, CAPAs, Change Controls, and documentation management.

Work with Quality, Facilities, and cross-functional teams to ensure timely execution, regulatory readiness, and a state-of-the-art pest control program.

Qualifications

• Education as stated: Doctorate with 2+ years of engineering experience, or Masters with 6 years, or Bachelor's with 8 years of related experience.
• Strong knowledge of Quality Systems, deviations, CAPA management, Change Controls, and controlled documentation.
• Experience supporting OEFM electronic forms or similar electronic quality/facilities management systems preferred.
• Understanding of pest control programs in a regulated manufacturing environment.
• Knowledge of FDA regulatory requirements and other authorities.
• Excellent organization, communication, and problem-solving skills.
• Detail-oriented with focus on quality, compliance, and timely execution.

Responsibilities

• Provide primary support for Quality Systems activities including deviations, CAPAs, Change Controls, and related quality documentation.
• Investigate and document deviations from procedures or specifications following SOPs.
• Collaborate with Quality team to initiate, implement, monitor, and close CAPAs in a timely manner.
• Ensure Quality Systems records are complete, accurate, compliant, and inspection-ready.
• Facilitate and manage documentation changes related to facilities and engineering processes.
• Support creation, review, routing, and tracking of OEFM electronic forms.
• Collaborate with cross-functional teams to resolve form-related questions or issues.
• Support the Pest Control program and coordinate with external vendors and internal teams.
• Assist Change Control by evaluating proposed changes and maintaining records for regulatory inspections.

Skills

Quality Systems

CAPA management

Change Controls

Documentation

Regulatory knowledge

Education

Doctorate in Engineering

Master's in Engineering

Bachelor's in Engineering

Tools

OEFM electronic forms

Electronic quality systems

Job description

Juncos, Puerto Rico

We are seeking a Facilities and Engineering Support Specialist to maintaining the integrity and compliance of the manufacturing facility. This role involves providing crucial support in Quality Systems, including deviations, Corrective and Preventive Actions (CAPAs), Change Controls, documentation changes, pest control program management support, and OEFM electronic forms.

Key Responsibilities

1. Quality Systems

• Provide primary support for Quality Systems activities, including deviations, CAPAs, Change Controls, and related quality documentation.
  
• Investigate and document deviations from established procedures or specifications following applicable Standard Operating Procedures (SOPs).
  
• Work closely with the Quality team and relevant stakeholders to initiate, implement, monitor, and close effective CAPAs in a timely manner.
  
• Ensure Quality Systems records are complete, accurate, compliant, and inspection-ready.
  

2. Documentation Changes

• Facilitate and manage documentation changes related to facilities and engineering processes.
  
• Ensure that documentation changes adhere to regulatory guidelines, internal quality standards, and industry best practices.
  
• Collaborate with relevant stakeholders to implement documentation changes efficiently.
  

3. OEFM Electronic Forms

• Provide support for the creation, completion, review, routing, and tracking of OEFM electronic forms.
  
• Ensure OEFM electronic forms are completed accurately, maintained in accordance with applicable procedures, and processed within required timelines.
  
• Collaborate with F&E, Quality, and other cross-functional teams to resolve form-related questions or issues.
  

4. Pest Control Program

• Support the transformation of the Pest Control program into a state of the art program.
  
• Collaborate with external pest control vendors and internal teams to address and resolve any pest control issues.
  
• Support the documentation and records related to the pest control program.
  

5. Change Controls

• Support the Change Control process by evaluating proposed changes to facilities, utilities, equipment, and critical utilities.
  
• Collaborate with stakeholders to assess the impact of changes and ensure proper documentation and implementation.
  
• Maintain Change Control records and provide support during regulatory inspections.
  

Requirements

• Education: Doctorate degree and 2 years of Engineering experience or, Master’s degree and 6 years of Engineering experience or Bachelor’s degree and 8 years of directly related experience
  
• Strong knowledge and demonstrated experience with Quality Systems, particularly deviations, CAPA management, Change Controls, and controlled documentation.
  
• Some Experience supporting OEFM electronic forms or similar electronic quality and facilities-management systems preferred.
  
• Some understanding of pest control programs within a regulated manufacturing environment.
  
• Knowledge of regulatory requirements, including FDA and other relevant authorities.
  
• Excellent organizational, communication, and problem-solving skills.
  
• Detail-oriented with a focus on quality, compliance, and timely execution.