Overview
Quality Manager Jobs in Olive Branch, USA at Spectra Tech, Inc.
Spectra Tech, Inc. is hiring for a Quality Manager in Olive Branch, MS.Job Description
The Quality Assurance Manager is responsible for maintaining the Quality Management System (QMS) and ensuring compliance with FDA cGMP regulations (21 CFR Parts 210/211). This role oversees product release, investigations, documentation control, and inspection readiness in support of OTC drug manufacturing operations.
ResponsibilitiesQuality Management System
- Manage and maintain the Quality Management System (QMS)
- Ensure compliance with 21 CFR Parts 210/211
- Oversee key quality systems, including:
- Maintain inspection readiness at all times
Batch Record Review & Product Release
- Review and approval of:
- Ensure completeness, accuracy, and compliance prior to release
- Authorize release or rejection of:
Regulatory Compliance
- Ensure compliance with:
- Support regulatory submissions and responses
- Lead preparation for:
- Participate in responses to FDA observations (e.g., Form 483)
Investigation & CAPA Management
- Approve corrective and preventive actions
Supplier & Material Qualification
- Approve supplier qualification activities
- Review supplier documentation:
- Support incoming material disposition decisions
Documentation Control
- Review and approval of:
- Ensure controlled document issuance and revision tracking
Validation & Qualification Support
Collaborate with technical teams to support:
Complaint Handling & Recall Support
Training Program Oversight
- Support onboarding of quality-related roles
Internal Audit Program
- Support continuous improvement initiatives
- Verify effectiveness of corrective actions
Educational Requirements
- Bachelor’s degree in Chemistry, Microbiology, Pharmaceutical Sciences, Chemical Engineering, Life Sciences, or a related technical discipline preferred
Experience Requirements
- Minimum of 5 years of experience in OTC drug manufacturing Quality Assurance
- Direct experience with FDA cGMP compliance
- Experience with batch record review and product release authority
- Experience managing deviations and CAPA processes
- Experience participating in internal or external audits
Preferred Experience
- Experience interacting with FDA inspection
- Experience in combination cosmetic/OTC manufacturing environments
At Spectra Tech, Inc., our recruitment team is powered by real people in real time-personally reviewing every application with care and integrity. We take pride in identifying and recruiting top-tier talent while maintaining full alignment with federal regulations, EEOC standards, and fair hiring practices that reflect our commitment to excellence and equity
Spectra Tech, Inc. is committed to hiring and retaining a diverse workforce. We are an Equal Employment Opportunity (EEO) employer. It is the policy of the Company to provide equal employment opportunities to all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information. We are also an E-verify employer.
Title: Quality Manager
Company: Spectra Tech, Inc.
Location: Olive Branch, USA
Category:
