Job Description
Senior Quality Assurance Associate
About Us:
Carie Boyd Pharmaceuticals is a national 503B FDA outsourcing registered facility, enabling us to meet the needs of our patients and prescribers through a variety of office use products including but not limited to injectables, pellets, and topicals. Being a member of the Carie Boyd team means prioritizing patient needs, dedication to quality, and the drive to continue to scale our innovative business in new and diverse ways.
Job Description
The Senior Quality Assurance Associate provides guidance on interpretation of regulatory requirements, leads internal and external audits, and coordinates with production to write and review GMP documents.
Responsibilities
· Under the direction of the Quality Director, the Senior QA Associate will assist with the overall development, implementation, and management of the Quality Management System (QMS)
· Coordinates with production to write standard operating procedures, protocols, risk assessments, reports, and other GMP documents
· Ensures standard operating procedures are written and implemented in compliance with the company’s policies, government regulations, and industry best practices
· Oversees complaint intake process, and assists production with completing complaints, investigations, and deviations in a timely manner
· Writes Annual Product Review (APR) reports and ensures maintenance to established review periods
· Creates raw material and finished product specifications, ensuring adherence to USP/NF Monographs and other regulatory requirements
· Performs risk assessments and vendor evaluation activities as part of Vendor Qualification
· Performs internal/external audits and participates in external audits involving regulatory agencies
· Evaluates and recommends alternative auditing procedures for continuous improvement
· Performs GMP document review, as needed
· Assist Quality Management with other QA duties, as needed
Qualifications:
· Bachelor’s degree or higher in a life science or related discipline or 4 + years in GMP pharmaceutical manufacturing, 503b outsourcing facility, or cosmetic manufacturing.
· Strong working knowledge of cGMP and GDP
· 2 or more years of experience with technical writing
· Strong documentation skills
Confidentiality
The employee must maintain the confidentiality of company information and, pursuant to State and Federal Law (including the Health Insurance Portability and Accountability (HIPAA) Act of 1996), protected health information.
EOE/ADA
Carie Boyd Pharmaceuticals is an Equal Opportunity Employer. In compliance with the Americans with Disabilities Act, Carie Boyd Pharmaceuticals will provide reasonable accommodations to qualified individuals with disabilities and encourages both prospective and current employees to discuss potential accommodations with the employer.
Company DescriptionWe specialize in compounding office-use and personalized prescription medications.
We specialize in compounding office-use and personalized prescription medications.
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