SPECIALIST QA

Quality Consulting Group, LLC; Juncos (PR); On-site; USD 70,000 - 110,000; Full time

Job summary

Quality Consulting Group, LLC is seeking a talented, highly motivated quality professional to join our team in Puerto Rico and the USA, contributing to world-class manufacturing quality and environmental monitoring programs.

You will support deviations, change controls, CAPAs, and validation activities, preparing GMP documentation and reports. Collaboration with cross-functional teams and participation in audits are expected, ensuring compliance with cGMP and applicable regulations.

Qualifications

• Experience with GMP quality systems and handling deviations, change controls, CAPAs, and GMP documentation management.
• Proven ability in validation, commissioning and qualification (IQ/OQ/PQ) of manufacturing equipment and laboratory instrumentation, including testing.
• Strong technical writing skills and review/approval of GMP documentation, reports, procedures, protocols, and forms.
• Solid understanding of cGMP, FDA regulations, and industry best practices for validation and quality compliance.

Responsibilities

• Supports GMP building Environmental Monitoring processes and reports.
• Participates in or leads risk assessments for sampling sites in GMP areas.
• Assists change controls, deviations, audit processes; provides support from Environmental Control perspective.
• Participates in forums and meetings to present data-driven actions and recommendations.
• Ensures facilities and processes comply with cGMP and applicable regulations.
• Supports internal/external audits and continuous improvement initiatives.

Skills

Quality Systems

Technical Writing

Documentation management

GMP compliance

IQ/OQ/PQ

Education

Bachelor's in sciences with concentration in any science discipline such as Engineering, Biology, Chemistry, Physics, Computer, etc.

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's site 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.

Quality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.