Senior Quality Assurance Associate at Carie Boyd Pharmaceuticals

Job Description 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 Description We specialize in compounding office-use and personalized prescription medications. Company Description We specialize in compounding office-use and personalized prescription medications.