System One Services Sr. Quality Assurance Associate - Pharmaceuticals in Baltimore, Maryland
Sr. Quality Assurance Associate - PharmaceuticalsBaltimore, Maryland
Category:Scientific & Clinical
Title: Sr. Quality Assurance Associate, Pharmaceuticals
Location: Baltimore, MD
Schedule: M-F 40 hours
Target Start Date: 11/16/20
Prepares, reviews and issues required pharmaceutical quality documentation
Provides input on quality control procedures.
Provides oversight for the development and maintenance of pharmaceutical quality programs.
Provides expertise and guidance in interpreting pharmaceutical policies.
Leads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits.
Performs pharmaceutical batch / lot record review to ensure that all reviewed records have been executed per procedure.
Conducts investigations determine appropriate corrective actions, CAPA.
Investigates product complaints and conducts follow-up with customer.
Reviews executed commercial production records.
BS/BA or MS in Chemistry; or closely related field required
Quality Assurance experience for commercial Pharmaceutical Manufacturing.
Demonstrated experience performing batch record review
Computer skills including a working knowledge of Microsoft Office (Access, PowerPoint, Word, Excel, and Microsoft TEAMS)
Working knowledge of Trackwise desirable
Ability to work independently with minimal supervision and direction
Joule, a System One division is a leader in specialized workforce solutions and integrated services. With more than 6,000 employees and roughly 50 offices throughout the U.S. we provide scientific, clinical, engineering, energy, IT, legal and administrative staffing services. For more than 40 years, we have delivered workforce solutions and integrated services to clients nationally.