Category: Scientific & Clinical
Title: QA Analyst II - Biomanufacturing
Location: Baltimore, MD
Type: Contract with possible hire
Start date: Immediate
- Support/execute QA on the Floor program, raw material release and batch record review
- Support/execute revision and creation of Standard Operating Procedures in document management system
- Support internal customers in manufacturing, QC, Engineering and Facilities, Validation, Supply Chain, Procurement and QA
- Support the generation of QA operations metrics
- Approve Quality Notifications (Deviations, CAPA’s and Change Controls)
- Exercise judgment within defined site procedures to determine appropriate action for resolution of technical issues
- Receive assignments in the form of objectives to help achieve department goals
- Participate in company sponsored training
- Provide Quality input/support to investigations, CAPA’s and changes
- Support site inspection readiness strategy and activities
- Support internal audits per audit schedule
- BS degree or equivalent level of skill and experience.
- 2-4 years’ experience supporting GMP manufacturing; supporting QA activities
- Preferred experience in biologic drug substance manufacture
- Experienced in application of GMP principles; FDA audits
- Strong computer skills with the Microsoft Office product line.
- Ability to effectively communicate (orally and written) with all levels of personnel at multiple company locations.
- Experienced with US, EU and Canadian pharmaceutical regulations, ISO standards
- Strong communication skills: oral/written and listening
- Ability to work individually and in a team environment
- Ability to work under pressure and analyze processes within scheduled timeframes
- Strong presentation skills, including written and verbal communication skills
- Experience in SAP and Technical Writing
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.