Quality Systems Specialist - GMP Compliance & TrackWise

ALLTECH CONSULTING SVC INC; Fort Wayne (IN); On-site; USD 60,000 - 80,000; Full time

Job summary

ALLTECH CONSULTING SVC INC is looking for a temporary Quality Management Systems Specialist for its Greendale, Indiana site. This role focuses on maintaining and improving quality systems, supporting compliance activities, and overseeing documentation.

The ideal candidate should have a minimum of 2 years experience in a GMP-regulated environment, knowledge of relevant regulations, and proficiency with TrackWise. Strong communication and organizational skills are essential for this role.

Qualifications

• 2+ years of experience in a GMP-regulated environment, preferably in pharmaceuticals or dietary supplements.
• Experience with 21 CFR 111, 21 CFR 211, or 21 CFR 11.
• Working knowledge of Quality Systems and Quality Assurance.

Responsibilities

• Support site-level quality systems including Change Control and Deviation processes.
• Ensure timely completion of documentation tasks.
• Support internal audits by preparing required documentation.

Skills

GMP knowledge

Quality Systems knowledge

Communication skills

Organizational skills

Time management

Tools

TrackWise

Microsoft Office Suite

Job description

ALLTECH CONSULTING SVC INC is looking for a temporary Quality Management Systems Specialist for its Greendale, Indiana site. This role focuses on maintaining and improving quality systems, supporting compliance activities, and overseeing documentation.

The ideal candidate should have a minimum of 2 years experience in a GMP-regulated environment, knowledge of relevant regulations, and proficiency with TrackWise. Strong communication and organizational skills are essential for this role.