Quality Systems Specialist: GMP & Compliance Leader

RiseMe; Spring Hill (TN); On-site; USD 50,000 - 75,000; Full time

Job summary

RiseMe is seeking a Quality Systems Specialist to oversee the Quality Management System and ensure products meet internal and customer specifications. The role covers regulatory compliance (GMPs, 21 CFR 111/117, GFSI), batch record reconciliation, audits, and complaint handling.

Ideal candidates are detail-oriented, organized, with 1–2 years’ relevant experience, strong communication, and proficiency in Microsoft Office. Office-based with warehouse rounds and potential PPE requirements.

Qualifications

• High School Diploma required; some college experience preferred.
• 1-2 years’ experience in a similar setting.
• Detail oriented and highly organized.
• Working knowledge of Microsoft Office and general computer concepts.
• Intermediate math, communication, and problem solving skills.
• Strong documentation practices and record keeping skills.
• Excellent written and oral communication skills.
• Ability to type 35 wpm.
• Ability to follow company processes and procedures.
• Ability to work without direct supervision.
• Ability to lift up to 15 lbs.
• Ability to sit and stand for extended periods of time.
• Ability to work around a variety of different smells and aromas.
• Ability to view a computer screen and type for extended hours.
• Work environment is normally in an office setting. Must be able to make frequent rounds in a warehouse environment.

Responsibilities

• Oversee the Quality Management System (QMS) to ensure compliance with regulations and customer requirements (GMPs as listed in 21 CFR 111 and 117, and GFSI).
• Review and approve completed production work orders.
• Assure that batch records are reconciled and documented completely (yield, label reconciliation, waste, etc.).
• Maintain Good Documentation practices and record keeping.
• Complete QC Daily reports.
• Oversee and maintain internal audit program.
• Oversee and maintain non-conformance program.
• Responsible for external communications regarding complaint handling.
• Oversee and maintain traceability system.
• Provide document control support and regulatory support as needed.
• Monitor allergen handling through cleansing and labeling.
• Meet goals and objectives as outlined by Executive Management.
• Perform other duties as deemed necessary.

Job description

RiseMe is seeking a Quality Systems Specialist to oversee the Quality Management System and ensure products meet internal and customer specifications. The role covers regulatory compliance (GMPs, 21 CFR 111/117, GFSI), batch record reconciliation, audits, and complaint handling.

Ideal candidates are detail-oriented, organized, with 1–2 years’ relevant experience, strong communication, and proficiency in Microsoft Office. Office-based with warehouse rounds and potential PPE requirements.