Aditi Consulting
Payrate:
$30.00 - $35.00/hr.
Summary: We are seeking a temporary Quality Management Systems Specialist to join our dynamic Quality Assurance team at our Greendale, Indiana site. This role is critical to the integrity and continuous improvement of our site's Quality Systems and will be responsible for supporting key compliance and quality system activities such as entry of Change Controls, Deviations, Complaints, and CAPAs into Track Wise. The ideal candidate will bring an understanding of GMP principles, experience in pharmaceutical or dietary supplement manufacturing, and basic user knowledge of electronic quality systems (i.e. Track Wise or similar).
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.
Skills, Experience, Qualifications:
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 Track Wise and/or EDMS or equivalent Lean Six Sigma or similar continuous improvement training Project Management
Pay Transparency:
The typical base pay for this role across the U.S. is:
$30.00 - $35.00/hr.
Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience and the benefits package you select. Full-time employees are eligible to select from different benefits packages. Packages may include medical, dental, and vision benefits, 10 paid days off, 401(k) plan participation, commuter benefits and life and disability insurance.
Consent to Communication and Use of AI Technology: By submitting your application for this position and providing your email address(es) and/or phone number(s), you consent to receive text (SMS), email, and/or voice communication whether automated (including auto telephone dialing systems or automatic text messaging systems), pre-recorded, AI-assisted, or individually initiated from Aditi Consulting, our agents, representatives, or affiliates at the phone number and/or email address you have provided. These communications may include information about potential opportunities and information. Message and data rates may apply. Message frequency may vary.
You represent and warrant that the email address(es) and/or telephone number(s) you provided to us belong to you and that you are permitted to receive calls, text (SMS) messages, and/or emails at these contacts. You also acknowledge and agree to Aditi Consulting LLC's use of AI technology during the sourcing process, including calls from an AI Voice Recruiter. AI is used solely to gather data and does not replace human-based decision-making in employment decisions. Calls may be recorded.
Consent is not a condition of purchasing any property, goods, or services. You may revoke your consent at any time by replying "STOP" to messages or by contacting privacy@aditiconsulting.com.
For information about our collection, use, and disclosure of applicant's personal information as well as applicants' rights over their personal information, please see our Privacy Policy
#AditiConsulting #25-22882
$30.00 - $35.00/hr.
Summary: We are seeking a temporary Quality Management Systems Specialist to join our dynamic Quality Assurance team at our Greendale, Indiana site. This role is critical to the integrity and continuous improvement of our site's Quality Systems and will be responsible for supporting key compliance and quality system activities such as entry of Change Controls, Deviations, Complaints, and CAPAs into Track Wise. The ideal candidate will bring an understanding of GMP principles, experience in pharmaceutical or dietary supplement manufacturing, and basic user knowledge of electronic quality systems (i.e. Track Wise or similar).
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.
Skills, Experience, Qualifications:
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 Track Wise and/or EDMS or equivalent Lean Six Sigma or similar continuous improvement training Project Management
Pay Transparency:
The typical base pay for this role across the U.S. is:
$30.00 - $35.00/hr.
Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience and the benefits package you select. Full-time employees are eligible to select from different benefits packages. Packages may include medical, dental, and vision benefits, 10 paid days off, 401(k) plan participation, commuter benefits and life and disability insurance.
Consent to Communication and Use of AI Technology: By submitting your application for this position and providing your email address(es) and/or phone number(s), you consent to receive text (SMS), email, and/or voice communication whether automated (including auto telephone dialing systems or automatic text messaging systems), pre-recorded, AI-assisted, or individually initiated from Aditi Consulting, our agents, representatives, or affiliates at the phone number and/or email address you have provided. These communications may include information about potential opportunities and information. Message and data rates may apply. Message frequency may vary.
You represent and warrant that the email address(es) and/or telephone number(s) you provided to us belong to you and that you are permitted to receive calls, text (SMS) messages, and/or emails at these contacts. You also acknowledge and agree to Aditi Consulting LLC's use of AI technology during the sourcing process, including calls from an AI Voice Recruiter. AI is used solely to gather data and does not replace human-based decision-making in employment decisions. Calls may be recorded.
Consent is not a condition of purchasing any property, goods, or services. You may revoke your consent at any time by replying "STOP" to messages or by contacting privacy@aditiconsulting.com.
For information about our collection, use, and disclosure of applicant's personal information as well as applicants' rights over their personal information, please see our Privacy Policy
#AditiConsulting #25-22882