Sr. Quality Assurance Associate
Avara Pharmaceutical Services
Summary
Review and approve batch records, deviation investigations, and reports. Provide inter- and intradepartmental support in the preparation and review of documentation related to and including manufacturing processes, equipment, and computer systems that affect GMP-related activities. Administers the QA deviation and CAPA system, internal audit system, supplier audit system, and all other necessary quality systems. Provides GMP guidance to other departments and project teams.
Job description
Purpose & Scope
Review and approve batch records, deviation investigations, and reports. Provide inter- and intradepartmental support in the preparation and review of documentation related to and including manufacturing processes, equipment, and computer systems that affect GMP-related activities. Administers the QA deviation and CAPA system, internal audit system, supplier audit system, and all other necessary quality systems. Provides GMP guidance to other departments and project teams.
Essential Job Responsibilities
- Assist in the investigation, reporting, and resolution of major deviations
- Review and approval of validation protocols and reports
- Review and approval of all GMP document revisions including SOP's, MPR's, specifications, test methods, etc.
- Administration of the deviation and CAPA system
- Administration of the internal audit and supplier audit program
- Performance of internal and external audits
- Host and support for audits of APT by third parties, Avara corporate, and all regulatory bodies
- Review and approval of CAPA plans and completion
- Follow up on CAPA and deviation to ensure effectiveness
- Representation of QA on site-wide and regional and global project teams
- Provide GMP guidance to all affected departments at APT
- Development and preparation of all QA metrics and reporting the results to APT and regional and global management (Q10)
- Development and administration of APT OJT and GMP training program
- Use of statistical analysis tools to evaluate data
- Development and use of risk assessment tools
Qualifications
Required: 3-5 years previous experience with GMP within the pharmaceutical industry; 3-5 years direct QA experience; Good verbal and written communication skills with basic computer skills; Attention to detail and accurate record keeping; Able to multi-task; Basic understanding and knowledge of GMPs and the pharmaceutical industry, quality practices and standards; Experience with statistical data analysis preferred; Must be able to read, write and understand the English language; Must be able to work independently with some supervision; Must be able to gather and evaluate data to make sound decisions; Must be able to exercise judgment in the resolution of problems; Office environment; must be able to sit at a desk for extended periods of time; Occasionally requires ability to climb stairs and the ability to perform while wearing required personal protective equipment, such as respiratory protection, eye protection, hearing protection and safety shoes; Knowledge of CFR parts 210 & 211; Experience with Microsoft programs (Excel, Word, etc.). Preferred: Bachelor's degree.
Requirements
- 3-5 years previous experience with GMP within the pharmaceutical industry
- 3-5 years direct QA experience
- Good verbal and written communication skills with basic computer skills
- Attention to detail and accurate record keeping
- Able to multi-task
- Basic understanding and knowledge of GMPs and the pharmaceutical industry, quality practices and standards
- Experience with statistical data analysis preferred
- Must be able to read, write and understand the English language
- Must be able to work independently with some supervision
- Must be able to gather and evaluate data to make sound decisions
- Must be able to exercise judgment in the resolution of problems
- Office environment; must be able to sit at a desk for extended periods of time
- Occasionally requires ability to climb stairs and the ability to perform while wearing required personal protective equipment, such as respiratory protection, eye protection, hearing protection and safety shoes
- Knowledge of CFR parts 210 & 211
- Experience with Microsoft programs (Excel, Word, etc.)
- Bachelor's degree (preferred)
Company overview
Avara Pharmaceutical Services is an international contract development and manufacturing organization (CDMO) headquartered in Norman, Oklahoma. Founded in 2016, the company is committed to delivering quality clinical-to-commercial-scale drug product manufacturing, packaging, and technical services to the pharmaceutical industry. Avara's core capabilities include oral solid dose drug products, encompassing potent compounds and targeted release formulations, manufactured at its facilities in Aiken, South Carolina, Norman, Oklahoma, and Arecibo, Puerto Rico. Its Liscate, Italy facility specializes in liquid and lyophilized fill-finish of sterile injectable products, including small volume parenterals. Across its global locations, Avara offers integrated packaging solutions designed to optimize cost and minimize time to market for clients. With decades of combined experience in supply chain, commercialization, product launch, and product transfer, the company provides a flexible, client-centric approach backed by strong regulatory compliance expertise. Avara employs between 501 and 1,000 people and positions itself as a global contract manufacturing partner delivering reliable, secure supply chains for the therapies patients depend on.