Ampcus, Inc
Overview
Ampcus Inc. is a certified global provider of a broad range of Technology and Business consulting services. We are in search of a highly motivated candidate to join our talented Team.
Position Job Title: Quality Management Systems Specialist Location: Greendale, IN
Responsibilities
Quality Systems Oversight:
Support site-level quality systems such as Change Control and Deviation processes in accordance with internal procedures and regulatory expectations.
Ensure timely and thorough completion of assigned documentation tasks.
Support cross-functional teams quality system updates.
Computerized System Compliance:
Support Data Integrity initiatives for electronic systems including TrackWise, EDMS, and other validated platforms.
Participate in system upgrades, validation activities, and periodic reviews to ensure ongoing compliance.
Documentation & Audit Support:
Collaborate with Document Control and QA teams to ensure controlled documents are accurate, current, and compliant.
Support internal, client, and regulatory audits by preparing documentation as assigned.
Assist in batch record review/filing, complaint investigation initiation, and audit readiness activities as needed.
Required Qualifications and Experience
Required:
2 years of experience in a GMP-regulated environment (pharmaceutical or dietary supplement preferred).
Experience with 21 CFR 111, 21 CFR 211, or 21 CFR 11.
Working knowledge of Quality Systems and Quality Assurance.
Experience with Microsoft Office Suite.
Excellent written and verbal communication skills.
Strong organizational and time management abilities.
Preferred
Experience with TrackWise and/or EDMS or equivalent.
Lean Six Sigma or similar continuous improvement training.
Project Management.
Ampcus is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veterans or individuals with disabilities.
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Position Job Title: Quality Management Systems Specialist Location: Greendale, IN
Responsibilities
Quality Systems Oversight:
Support site-level quality systems such as Change Control and Deviation processes in accordance with internal procedures and regulatory expectations.
Ensure timely and thorough completion of assigned documentation tasks.
Support cross-functional teams quality system updates.
Computerized System Compliance:
Support Data Integrity initiatives for electronic systems including TrackWise, EDMS, and other validated platforms.
Participate in system upgrades, validation activities, and periodic reviews to ensure ongoing compliance.
Documentation & Audit Support:
Collaborate with Document Control and QA teams to ensure controlled documents are accurate, current, and compliant.
Support internal, client, and regulatory audits by preparing documentation as assigned.
Assist in batch record review/filing, complaint investigation initiation, and audit readiness activities as needed.
Required Qualifications and Experience
Required:
2 years of experience in a GMP-regulated environment (pharmaceutical or dietary supplement preferred).
Experience with 21 CFR 111, 21 CFR 211, or 21 CFR 11.
Working knowledge of Quality Systems and Quality Assurance.
Experience with Microsoft Office Suite.
Excellent written and verbal communication skills.
Strong organizational and time management abilities.
Preferred
Experience with TrackWise and/or EDMS or equivalent.
Lean Six Sigma or similar continuous improvement training.
Project Management.
Ampcus is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veterans or individuals with disabilities.
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