SPECIALIST QA

Quality Consulting Group, LLC; Juncos (PR); On-site; USD 60,000 - 90,000; Full time

Job summary

Quality Consulting Group, LLC in Puerto Rico and the USA seeks a talented Quality professional to join our team, focusing on cGMP compliance, validation, and quality systems support in manufacturing environments.

You will contribute by handling deviations, change controls, CAPAs, and GMP documentation, perform risk assessments, and assist in internal/external audits and inspections. Strong technical writing and cross-functional collaboration are essential.

Qualifications

• Qualify in Quality Systems with Deviations, Change Controls, CAPAs and GMP documentation.
• Experience in Validation, Commissioning and Qualification (IQ/OQ/PQ) of equipment and lab instruments.
• Strong technical writing for GMP documentation and reports.

Responsibilities

• Supports client site GMP buildings Environmental Monitoring process.
• Generates Environmental Monitoring and Critical Utilities trend reports.
• Leads and participates in risk assessments for sampling sites.
• Assists in change controls, deviations, and audit processes for Environmental Control.
• Represents data in forums and participates in Management Review meetings.
• Ensures compliance with cGMP and applicable regulations.
• Supports internal/external audits and inspections as needed.

Skills

Quality Systems

Deviation management

Change controls

CAPA management

Technical writing

GMP compliance

Education

Bachelor's in sciences

Job description

QUALITY CONSULTING GROUP, a leader inthe pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you’ll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA.

Responsibilities

• Supports the client'ssite GMP buildings Environmental Monitoring Process
• Generates Environmental Monitoring and Critical Utilities trend reports
• Participates and or Leads Risk Assessments to evaluate sampling sites for routine monitoring of GMP areas
• Provides assessments to change control records, deviations, audit processes that need support form the Environmental Control perspective
• Participate in forums such as the Environmental Control Network, Aseptic Council and or Contamination Control Network as assigned
• Attends client's GMP Buildings Quality system forums and or Management Review meetings to present environmental and critical utilities data and recommend actions based on the data evaluation
• Ensures that facilities, equipment, materials, organization, processes, procedures, and products comply with cGMP practices and other applicable regulations
• Supports Continuous Improvement initiatives, programs, and projects
• Collaborates cross functionally as needed to ensure the Quality Management System processes are performed in alignment with established procedures
• Alerts senior management of quality, compliance, supply, and safety risks
• Supports internal/external audits and inspections as needed

Qualifications

• Bachelor's in scienceswith concentration in any science discipline such as Engineering, Biology, Chemistry, Physis, Computer, etc
• Experienced in Quality Systems, including Deviations, Change Controls, CAPAs, and GMP documentation management.

• Quality Professional with experience in Validation, Commissioning, and Qualification (IQ/OQ/PQ) of manufacturing equipment and laboratory instrumentation, including functional testing.

• Strong expertise in Technical Writing and preparation, review, and approval of GMP technical documentation, including validation reports, technical reports, procedures, protocols, and forms.

• Strong understanding of cGMP, FDA regulations, and industry best practices for validation and quality compliance.