Quality Assurance Supervisor/Manager

2 weeks ago

Irving, United States Carie Boyd Pharmaceuticals Full time
Job DescriptionJob Description

Quality Assurance Supervisor/Manager

 

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 Quality Assurance Supervisor/Manager position manages quality assurance systems and coordinates activities associated with batch review and release, vendor qualification, and quality event management. 

Responsibilities

·        Under the direction of the Quality Director, the QA Supervisor/Manager will assist with the overall development, implementation, and management of the Quality Management System (QMS)

·        Coordinates activities for employees engaged in batch record review based on production schedule

·        Assigns and performs training for new QA personnel

·        Oversees the maintenance of paper logbooks and electronic logbooks

·        Ensures standard operating procedures are written and implemented in compliance with the company’s policies, government regulations, and industry best practices

·        Coordinates the review of existing SOP’s to ensure they are up to date and strictly followed

·        Oversees the document control program and provides assistance and training for the personnel performing QA document control activities

·        Oversees the monitoring, measurement, and review of internal processes (Change Control, CAPA, internal audits, Management Review, etc.)

·        Conducts root cause analysis for quality issues and facilitates corrective action and preventative action

·        Oversees vendor qualification program and assists with vendor qualifications activities, as needed

·        Oversees label control activities and conducts training for personnel responsible for label control

·        Participates in external audits involving regulatory agencies

·        Assist Director of Quality with other QA duties, as needed

Has the decision-making authority in the following areas:

·        Batch record review and release

·        Quality Event Management

·        Vendor Qualification Program

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 quality event management

·        2 or more years of experience with quality events and root cause analysis

·        Experience in batch record review and release preferred

·        Strong documentation skills

Title and pay dependent on experience. One to four years of management experience will be considered for the position with a supervisor title and greater than 4 years of experience may be considered for a manager title depending on depth of understanding and ability to manage the quality systems and release.

 

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.Company DescriptionWe specialize in compounding office-use and personalized prescription medications.

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