Job Description
Target Pay Rate: 35-46.74/hr **salary will be commensurate with experience
Job Description:
Primary Activities may include, but are not limited to the following:
• Evaluate and release products to other sites with the assurance that the goods were produced in conformance to all applicable policies/procedures and compliance with all governing regulations.
• Manage routine and complex deviations and complaints and assist in the coordination of significant investigations; assist in the coordination of report closures required by the external manufacturer.
• Support routine and complex change requests and support process modification change controls.
• Provide guidance in the preparation of metrics, procedures, and guidelines; provide proactive support in training and coaching to initiate quality improvements.
• Track and monitor operational and quality performance of the external manufacturer and work with supplier to develop CAPA plans, as needed.
• Gather, interpret, and report, in a timely manner data for internal Annual Product Review (when required).
• Participate with site visits to build relationships and monitor efforts to improve the external manufacturers quality and reliability through ongoing oversight and formal communication programs and forums.
• Acts as a resource for colleagues with less experience within own discipline; can provide minimal guidance on issue resolution and act as Subject Matter Expert (SME)
Qualifications: • Education: BS/MS in Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering (or equivalent) with minimum 5 years of relevant experience within Quality Systems, Quality Assurance, and Quality Control.
• Previous experience within the pharmaceutical industry or Medical Devices Combination Products with thorough knowledge of Quality Systems, Quality Assurance, and Quality Control.
• Must have working knowledge of regulatory expectations for the manufacture and/or testing of pharmaceutical products and/or Medical Devices Combination Products, with experience in quality, manufacturing, process validation and/or process technology transfer processes.
• Excellent technical, organizational, interpersonal, collaborative, and verbal/written communication skills.
• Experience with Quality functions supporting release and compliance activities or indirect involvement in Quality functions through execution of activities such as batch record/documentation reviews, investigations, corrective actions, complaints, quality system management, etc.
Required Skills: • Must have ability to make assessment of technical reports (example: investigations, product release) and determine acceptability based on organizational requirements.
• Must be able to handle multiple priorities at a time and immediately address urgent issues.
• Solves complex problems; takes a new perspective using existing solutions.
• Accountable for medium sized projects with minimal resource requirements, risk and/or complexity.
• Works independently, receives minimal guidance.
• Experience with administration and data entry of technical reports into internal databases.
• Explains difficult issues and works to build alignment around a complex situation.
• Ability to work across boundaries; demonstrated interpersonal, relationship building and leadership skills.
• Strong knowledge of External Manufacturing management, supply chain, and operations.
• Communicates easily in English both verbally and in writing.
• Lean Six Sigma Systems training is an advantage.
• Fluent in English language (reading, writing, and speaking)
Softwares:
• Knowledge and competency with various IT systems, including Comet-SAP, Midas (document storage system), Track Wise Complaints system (QCC4), and Trackwise Change Control (GCM).
Job Tags
Remote job, Contract work, Immediate start,