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Senior Specialist Quality Assurance - Level II (Pharma) Remote position

Company: Astrix Technology Group
Location: Jersey City
Posted on: June 4, 2021

Job Description:

Senior Specialist Quality Assurance - Level II (Pharma) Remote position

Qualifications:

Quality Assurance professional with at a minimum a BS Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering (or equivalent) Previous experience within the pharmaceutical industry 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.

Responsibilities:

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. 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. Knowledge and competency with various IT systems, including Comet-SAP, Midas (document storage system), Track Wise Complaints system (QCC4), and Track Wise Change Control (GCM). Accountable for medium sized projects with minimal resource requirements, risk and/or complexity. May act as a team or project lead and lead work of others as required; promotes teamwork and open discussion of

Keywords: Astrix Technology Group, Jersey City , Senior Specialist Quality Assurance - Level II (Pharma) Remote position, Other , Jersey City, New Jersey

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