Spectra Tech, Inc. is hiring for a Quality Manager in Olive Branch, MS.Job DescriptionThe 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:
- 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 SupportCollaborate 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
