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Quality ManagerSpectra Tech, Inc. • Olive Branch, Mississippi, United States
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Quality Manager

Spectra Tech, Inc.
  • US
    Olive Branch, Mississippi, United States
  • US
    Olive Branch, Mississippi, United States
Postuler Maintenant

À propos

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
Bachelors 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.
  • Olive Branch, Mississippi, United States

Compétences linguistiques

  • English
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