QA & Testing (1)

Job Description

Job Summary

The individual will work in the External Quality Assurance Department. This unit oversees contract manufacturing (3rd party manufacturing) operations, supply chain operations and supplier quality functions. This position supports the execution of quality systems including the external audit program. This position is responsible for successful, timely completion of goals and objectives that strengthen the Quality organization.

Responsibilities

• Support of Clinical Operations including Drug Substance, Bulk Drug Product Manufacture, Clinical Packaging & Labeling and oversight of Clinical CMOs and Distributers

• Reviewing QC data and COA approval.

• Review and approval of clinical data for stability and applicable data for CMC submissions.

• Liason with Regulatory as needed to ensure business/regulatory timelines are met.

• Provide QA guidance/review/approval for Product Development projects in Phase 1 to Phase 3.

• Oversee appropriate Quality Systems appropriate for Clinical Phase Materials.

• QA Contact for applicable Quality Systems related to R&D.

• Review and approved: Master Batch Records, executed batch records, deviations, CAPA and change controls.

• May lead investigations and nonconformance reviews.

• Reviewing and approving specifications, SOPs, validation protocols/reports, investigations, CAPAs, and change controls.

Education and Qualification:

• Bachelor’s degree in chemistry, biology or a related discipline

Minimum 5 years Quality Assurance experience supporting the manufacture of drugs, biologics, or devices.

• Experience in applying phase appropriate cGMP’s to Clinical Product Life Cycle.

• Understanding of quality systems, cGMPS and Regulatory Agency guidance as applicable to drugs or biologics.

• Excellent interpersonal and professional skills with the ability to communicate well orally and in writing.

• Strong Quality Assurance knowledge, previous experience in QC a plus.

• Must be able to prioritize and multitask in a dynamic environment.

• Quality experience in parenteral biotech manufacturing (aseptic or sterile processing)

• Experience working with contract manufacturers.

• Experience with Quality Control.

• Experience with packaging and labeling operations.

• Experience with TrackWise.

• Experience with Medical Device, Small Molecules and other pharmaceutical technologies

Qualifications