What are the responsibilities and job description for the Quality Assurance Manager position at ProRx Pharma 503B Outsourcing Facility?
Company Description
ProRx Pharma is an FDA-registered 503B facility focused on providing essential compounded sterile and non-sterile preparations. The company compounds products and formulations for medical institutions, physician offices, and 503A pharmacies, with a specialization in producing high-quality products to ensure patients have access to the medications they need during critical shortages.
ProRx is a fast-growing company, in the last year we have doubled the size of our manufacturing capabilities, hired on 30 staff members, and invested heavily in automation and compliance. We are looking for a qualified individual, eager to join a company during a high-growth state, who isn't afraid to take on new challenges.
Role Description
This is a full-time, on-site role located in Exton, PA. The Quality Assurance Manager will oversee and ensure compliance with regulatory standards and quality control processes. Daily tasks include developing and implementing quality assurance protocols, conducting audits, reviewing production processes, training staff on quality standards, and other duties as needed.
Qualifications
- Experience in developing and implementing quality assurance protocols and conducting audits
- Create and manage Document Control Systems
- Perform Deviations, Root Cause Analysis, CAPAs
- Knowledge of regulatory requirements and compliance standards in the pharmaceutical industry
- Strong understanding of cGMP, CFR 21 Part 11, 21 CFR Parts 210 & 211, 21 CFR Part 820
- Strong analytical and problem-solving skills
- Excellent communication and leadership skills
- Ability to train and mentor staff on quality standards
- Bachelor's degree in Pharmacology, Chemistry, or a related field
- Minimum of 3 years of experience in a quality assurance role, preferably in the pharmaceutical industry