Quality Engineering Supervisor - Pharmaceutical 9/2/2016
Fort Collins, CO
JOB DESCRIPTIONAPPLY PURPOSE AND SCOPE
Working in a team environment, this position has overall responsibility for coordination and execution of quality engineering activities in support of commercial products. The Quality Engineering Supervisor supports Quality Assurance by directly interacting with internal customers to ensure the quality of marketed products and compliance are within FDA and international regulatory requirements as well as the company's quality expectations.
ESSENTIAL DUTIES & RESPONSIBILITIES
* Responsible for quality reports and provide tracking and trending data for proactive resolutions and evaluation of product performance per established regulations and within schedule.
* Responsible for the completion of Annual Product Reports (APR) in a timely matter and in compliance with regulatory requirements for contents, trends, and approvals.
* Responsible for procedures and compliance related to APRs, Quality Metrics, Investigations/CAPA, yield calculations, and Failure Modes and Effects Analyses (FMEAs).
* Compiles data and creates Quality Management Review presentations and tracking of actions associated with the Management Review.
* Compiles and submits data for Quality Indicators (KPI) related to Investigations and CAPA.
* Participates in decision making process regarding product quality issues.
* Provides guidance and statistical evaluation to interpret analytical data associated with product release, stability reports, validation activities, laboratory investigations and non-conformance investigations to support the company's release and compliance decisions.
* Responsible for the quality of investigations, root cause analysis, identification of Corrective and Preventive Actions (CAPA) and establishing/measuring CAPA effectiveness.
* Supports process improvement initiatives for operational areas (Manufacturing, Logistics, QA, QC/Microbiology).
* Provides statistical support and DOE for internal investigations, validations and any Quality System continuous improvement action plan.
* Defines, identifies and applies product and process control methods such as developing control plans and identifying critical control points for sampling/inspection.
* Acts as a QA representative on project teams to define critical points and classify product defects.
* Interact with investigators/ auditors during regulatory inspections and marketing partner audits.
EDUCATION & EXPERIENCE
* Bachelor's degree in Chemistry, Engineering, Biology or other related fields.
* 5 or more years of Quality Engineering/Quality Assurance experience in a pharmaceutical, medical device or manufacturing industry.
* Previous supervisory experience of increasing complexity.
* Thorough knowledge of cGMPs, ISO, EU, and JP standards for pharmaceutical products.
* CQE/CQ preferred.