JT982 - SPECIALIST QUALITY CONTROL

Quality Consulting Group, LLC; Juncos (PR); On-site; USD 70,000 - 100,000; Full time

Job summary

QUALITY CONSULTING GROUP, LLC is seeking a technical specialist for testing and development in molecular biology and microbiology in Puerto Rico and the USA. You will work with a highly enthusiastic team in a world-class manufacturing environment.

Responsibilities include providing reports, data analysis, ensuring cross-functional communication, and maintaining GMP/GLP and safety compliance. The role may involve audits, document control, and regulatory interactions.

Qualifications

• Bachelor's Degree in Science (Preferred: Background Microbiology)
• Technical writing for microbiology method validation reports
• Knowledge in bioburden, endotoxin, low endotoxin recoveries, sterility testing, MMV and mycoplasma testing
• Provide technical support to the microbiology lab
• Design special studies
• Support deviation records owners as evaluating events and root cause
• Administrative shift

Responsibilities

• Technical specialist for testing and development in areas of molecular biology and microbiology.
• Focus is on the complex technical issues and scope is typically multi-organizational and/or multi-site and/or involving outside resources.
• Provide reports, data analysis and ensure flow of communication between technical groups including following up on and resolving issues that arise.
• Resolve technical issues and troubleshoot for assays as necessary
• Ensure lab compliance which includes: Implementing procedures that enhance GMP, GLP and safety.
• Manage existing and/or develop and implement new programs, processes and methodologies.
• Develop, revise and audit various complex controlled documents that may have multi-organizational and/or multi-site impact.
• Approve lab investigations, Lead audit teams
• May serve as subject matter expert to develop technical training.
• Represents the department/organization on various teams, Independently responsible for following through on multi-site action items.
• May interact with regulatory agencies regarding area(s) of responsibility including written responses.

Skills

Technical writing

Bioburden testing

Endotoxin testing

Sterility testing

Mycoplasma testing

Root cause analysis

GMP/GLP compliance

Audit support

Education

Bachelor's Degree in Science (preferred microbiology)

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:

• Technical specialist for testing and development in areas of molecular biology and microbiology.
• Focus is on the complex technical issues and scope is typically multi-organizational and/or multi-site and /or involving outside resources.
• Responsible for providing technical guidance, Provide reports, data analysis and ensure flow of communication between technical groups including following up on and resolving issues that arise.
• Resolve technical issues and troubleshoot for assays as necessary
• Ensure lab compliance which includes: Implementing procedures that enhance GMP, GLP and safety.
• Manage existing and/or develop and implement new programs, processes and methodologies.
• Develop, revise and audit various complex controlled documents that may have multi-organizational and/or multi-site impact.
• Approve lab investigations, Lead audit teams
• May serve as subject matter expert to develop technical training.
• Represents the department/organization on various teams, Independently responsible for following through on multi-site action items.
• May interact with regulatory agencies regarding area(s) of responsibility including written responses.

Qualifications:

• Bachelors' Degree in Science (Preferred: Background Microbiology)
• Technical Writing for Microbiology Method Validations reports for new product introductions
• Knowledge in Bioburden , Endotoxin , Low endotoxin recoveries , Sterility testing , MMV and Mycoplasma testing
• Provide Technical support to the microbiology lab
• Design special studies
• Support Deviation records owners as evaluating events and root cause
• Administrative Shift

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.