Oxford Global Resources is looking for a qualified pharmaceutical professional for a 100% remote position- Janssen project.
Responsibilities
- Maintain oversight for status of individual batches, including sampling, testing, deviations, and target release timelines; communicate status accurately and succinctly.
- Review batch documentation provided by external manufacturing site for compliance with cGMPs, Janssen standards, and product specifications.
- Ensure all required testing and documentation is provided and meets release requirements.
- Perform batch disposition in accordance with company procedures.
- Manage/track OMCL/CBER samples from EM to final shipment to government facility.
- Generate OMCL/CBER protocols for lot release.
- Enter data into eLIMS.
- Alert Supervision of any nonconforming results, out of trend, or out of specification results.
- Support supply chain logistics for on time shipment from CMO to Warehouse.
Requirements
- Bachelor's Degree with a concentration in engineering, science, or an equivalent technical discipline.
- Minimum of 4 years working in a pharmaceutical regulated environment.
- Experience with pharmaceutical aseptic processing operations or quality assurance.
- Detailed knowledge of cGMPs related to pharmaceutical production.
- Strong interpersonal and written/oral communication skills.
- Ability to quickly process complex information and make critical decisions with limited information required.
- Advanced degrees are a plus and may reduce the experience required.
Preferred Requirements
- Experience in the OMCL/CBER process for vaccine government approval/release.
- Proficient in applying process excellence tools and methodologies.
- Experience working with external manufacturers.
Conditions:
- Temporary position: 12 months.
- 100% remote position
- Salary: Very attractive and competitive- according to the skills and experience of the candidate
- Starting Day: ASAP
- Location: Remote
