Manufacturing Associate II – Upstream
| Company | Ultragenyx Pharmaceutical |
|---|---|
| Location | Bedford, MA, USA |
| Salary | $74900 – $92500 |
| Type | Full-Time |
| Degrees | Bachelor’s |
| Experience Level | Mid Level |
Requirements
- High school degree to BS in Engineering, Scientific Discipline or Business or equivalent in experience
- 2+ years experience in a Biologics Manufacturing setting
- Experience with viral vectors would be beneficial for this role
Responsibilities
- Be able to operate efficiently the Veeva Vault system for all quality documentation
- Ensure that high standards of cGMP are adhered to at all times
- Carry out the manufacturing review of the completed batch records in a timely manner per established targets
- Assist in Lot Disposition activities as required, including deviation follow ups, comment resolution in a timely manner to adhere to lot release timing
- Create, write and revise GMP documents and templates including batch records, SOPs, OJTs and logbooks
- Support the completion of change control forms and Deviations, plus subsequent implementation of changes and follow up actions
- Ensure that high standards of cGMP documentation completion are adhered to at all times and documentation is left in a reviewable condition at all times
- Demonstrate a thorough and complete understanding of safety requirements, GMP compliance of the plant and process
- Ongoing maintenance of own training, ensuring full training has taken place to support the execution of production activities
- Identify and drive any continuous Improvements to the process/equipment
- Identification of immediate actions/escalation needed to mitigate risk to product, employee safety or schedule as appropriate
- Initiation of MFG related Quality Incidents as required
- Support/ Drive through to completion any projects as required
- Ensure high standards of housekeeping are adhered to at all times
- Participate in internal/regulatory audits as required
- Ensure effective liaison and communication with other departments, maintaining good relations at all times
- Ensure that the appropriate safety policies and systems are adhered to in the GTMF suite. Ensure that objectives given are met in the appropriate agreed to timescale
Preferred Qualifications
- Experience with viral vectors would be beneficial for this role