Quality Manager

Quality Manager Spectra Tech, Inc. United States, Mississippi, Olive Branch Apr 09, 2026 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. Responsibilities Quality Management System Manage and maintain the Quality Management System (QMS)
Ensure compliance with 21 CFR Parts 210/211
Oversee key quality systems, including:
Document control
Change control
Deviations and investigations
CAPA program
Complaint handling
Internal audits
Training compliance
Maintain inspection readiness at all times
Batch Record Review & Product Release Review and approval of:
Master Batch Records
Executed Batch Records
Packaging Records
Laboratory documentation
Ensure completeness, accuracy, and compliance prior to release
Authorize release or rejection of:
Raw materials
Packaging components
Bulk product
Finished product
Regulatory Compliance Ensure compliance with:
FDA regulations
cGMP requirements
Internal SOPs
Applicable monographs (OTC)
Support regulatory submissions and responses
Lead preparation for:
FDA inspections
Customer audits
Third-party audits
Participate in responses to FDA observations (e.g., Form 483)
Investigation & CAPA Management Lead deviation investigations
Perform root cause analysis
Approve corrective and preventive actions
Track CAPA effectiveness
Ensure timely closure of quality events
Supplier & Material Qualification Approve supplier qualification activities
Review supplier documentation:
Certificates of Analysis
Quality Agreements
Audit reports
Support incoming material disposition decisions
Documentation Control Maintain SOP lifecycle management
Review and approval of:
SOPs
Protocols
Reports
Specifications
Validation documentation
Ensure controlled document issuance and revision tracking
Validation & Qualification Support Collaborate with technical teams to support: Process validation
Cleaning validation
Equipment qualification (IQ/OQ/PQ)
Method validation
Stability programs
Complaint Handling & Recall Support Manage product complaint investigations
Evaluate reportability
Support recall decisions if required
Maintain complaint trending program
Training Program Oversight Ensure personnel training compliance
Maintain training matrix
Verify GMP training effectiveness
Support onboarding of quality-related roles
Internal Audit Program Plan and execute internal audits
Identify compliance gaps
Support continuous improvement initiatives
Verify effectiveness of corrective actions
Other duties as needed
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
Equivalent experience may be considered
Preferred Experience
Experience interacting with FDA inspection
Familiarity with OTC products
Experience in combination cosmetic/OTC manufacturing environments
Exposure to stability program oversight 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.