Quality Control Inspector

Job Description

Company Overview

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.

Responsibilities

· Perform routine tasks including:

· Sampling: personnel monitoring (PM) and environmental monitoring (EM)

· Incubate and read sample plates (TSA and SDA) per standard operating procedures

· Send off PM & EM samples to contract laboratory for identification

· Confirm growth promotion test results

· Documenting actions

· Start-Up and In-Process Checks

· Label Verification

· Assist production to verify steps critical to quality of final product

· Perform visual inspections

· Enforce good hygiene practices and aseptic techniques in GMP areas

· Successfully pass garbing qualification to enter clean rooms

· Perform aseptic processing media fill simulations for personnel certifications and garb qualifications for personnel monitoring

· Clearly communicate and enforce the company’s quality expectations outlined in standard operating procedures in a productive manner

· Prepare product to be shipped to contract testing laboratories, select appropriate testing on portals, and correspond with laboratories, as needed

· Perform GDP review of documents, as needed

· Assist production with reconciliation, as needed

· Assist Quality Management with other Quality Control duties, as needed

Has the decision-making authority for the following:

· Start-up and shut down of compounding suites

Qualifications:

· Minimum 3 years combined GMP experience in any of the following: contract manufacturing, food packaging or manufacturing, medical device, and / or 503B outsourcing facility.

· Strong documentation skills

· Cleanroom experience preferred, but not required

· Aseptic Processing and Aseptic Technique skills preferred

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.

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

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