ONSITE - USRI - PLEASE NOTE SHIFT REQUIRMENT BELOW
***This position works a rotating shift schedule, Week 1: Monday, Tuesday, Friday, Saturday Week 2: Sunday, Wednesday, Thursday, ~12 hours per day 6:45 AM – 7:00 PM ***

Job Details:
In this vital role, will be responsible for PQA On the Floor in support of Manufacturing activities. This position requires working directly with Manufacturing staff during bulk drug substance operations to facilitate real-time decision-making regarding quality requirements and deviations.

Responsibilities Include the Following:
Provide Quality oversight to ensure that operations products are manufactured, tested, stored, and distributed according to current applicable regulations.
Ensure that facilities, equipment, materials, organization, processes, procedures and products follow cGMP practices and other applicable regulations.
Performs review and approval of cGMP processes, procedures, documents and records. Review logbooks, batch records, attachments, work orders, and other GMP documentation.
Ensure that deviations from established procedures are documented per procedures.
Ensure that production records and testing results are complete, accurate, and documented according to written procedures and cGMP requirements.
Alert management of quality, compliance, supply and safety risks.
Complete required assigned training to permit execution of required tasks.

Preferred Qualifications:
Bachelor’s Degree & 4 year of Quality/Manufacturing experience
cGMP Experience
Excellent written and verbal communication skills