What are the responsibilities and job description for the Specialist Product Quality position at The Steely Group?
As a Product Quality (PQ) Quality Assurance (QA) Specialist, you will actively provide quality assurance support to the PQ organization as a subject matter expert of quality system records.
In this team-based role you will directly add to the success of the Product Quality team by collaborating with diverse functional areas including Supply Chain, Manufacturing, Quality Control, Quality Assurance, Regulatory, Quality Engineering, International Quality and Process development on projects, issue resolution and investigations.
The QA Specialist will be encouraged to use technical abilities to lead and deliver quality assurance responsibilities while owning, reviewing, and / or approving Product Quality records and documentation including : product specifications, in-process control specifications, specification technical reports, annual product reviews (APRs), international expansion forms, change control records, appendix docs (data sheets and data analysis), Deviation Investigations / Root Cause Analysis, CAPAs, analytical comparability protocols, analytical comparability reports, and procedures.
As a team member you will be encouraged to use technical abilities to execute transactions in GMP systems (Veeva CDOCs, Trackwise, etc.) and may include additional business process support for APRs and audits, as needed. The QA specialist may also help with guiding products through the annual product review cycles.
Requirements / Qualifications :
Doctorate degree OR Master degree and 3 years of experience OR Bachelor degree and 5 years of experience OR Associate degree and 10 years of experience OR High school diploma / GED and 12 years of experience Preferred Qualifications :
Familiar with pharmaceutical sciences, quality, compliance and regulatory GMP requirements, associated with biologics and synthetic chemical manufacturing and QC testing.
B.S. in biochemistry, chemistry, biology, or a related protein or synthetic biotechnology sciences field or an equivalent level of biopharmaceutical experience with responsibility in a quality, analytical development, process development, pharmaceutics, regulatory, or manufacturing environment.
Previous experience using VEEVA, Trackwise and other quality systems.
Knowledge of biopharmaceutical bulk and drug product development, manufacturing, and / or Quality Control Testing
Strong project management skills.
General knowledge of cGMP and filing regulations, practices, and trends pertaining to the manufacture and testing of biopharmaceuticals.
Previous experience working on a cross-functional team in a matrix environment.
Excellent written and verbal communication skills, including facilitation and presentation skills.
