Mindlance
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.
III. Essential 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 TrackWise and/or EDMS or equivalent • Lean Six Sigma or similar continuous improvement training • Project Management
EEO:
"Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of - Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans."
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.
III. Essential 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 TrackWise and/or EDMS or equivalent • Lean Six Sigma or similar continuous improvement training • Project Management
EEO:
"Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of - Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans."