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Company: Fresenius Kabi
Location: Wilson
Posted on: January 10, 2022

Job Description:

Responsible for the quality assurance activities/decision making associated with cGMP manufacturing, processing, packaging and warehousing of product at the Wilson facility. Responsible for ensuring that the proper controls are instituted and maintained for equipment and associated processes, as well as the quality processes that govern them, and ensure they are effective, efficient, compliant and remain in a state of control. Work in partnership with manufacturing operations, research and development, quality control and assurance, engineering, maintenance to solve problems and provide support on compliance issues and corporate quality policy requirements.ResponsibilitiesPRINCIPAL ACTIVITIES PERFORMED BY THE INCUMBENT - Addresses daily quality concerns and questions related to operating and environmental concerns, ensuring compliance to all requirements established for product manufacturing and the systems supporting manufacturing. - Proactively takes ownership of quality processes and implements solutions in support of continuous improvement. - Ensure appropriate investigation and closure of incidents, change controls, and complaint investigations; direct implementation of appropriate solutions. - Assures standard operating procedures (SOPs) and batch records define the steps necessary to complete tasks. Writes, reviews, and updates documents as needed. - Provide additional support for batch record review and critical processing steps, in order to meet production and release scheduling. - Analyzes data, conducts root cause investigations, performs gap analyses and risk assessments, develops corrective or preventive actions, and implements procedural and physical changes to reduce defects, improve efficiencies, and ensure compliance with all regulatory requirements, e.g., cGMPs, FDA Guidelines, USP, ISPE, ISO etc. - Conducts internal audits of all critical processes and equipment, as well as the quality processes that oversee them, and identifies gaps in compliance and opportunities for improvement. - Assist with internal, corporate, 3rd party and federal/state inspections and audits. - Provides support to the plant during operational run times as well as during maintenance shutdown activities both of which include off shift coverage. - Provides training to appropriate personnel related to facilities and equipment quality system. - Prioritizes and efficiently completes tasks with minimal supervision and consistently delivers on commitments by date requested. - Performs other related duties as assigned.
REQUIREMENTS - B.S. degree, Technical science preferred. - 3 years' experience in a highly regulated industry required. - 3 years' experience in the pharmaceutical industry highly preferred. - 3 years' experience in change control preferred. - Experience with aseptic technique, statistical sampling (ANSI Z1.4 Sampling Plan). - Working knowledge of cGMP practices to include 21 CFR Part 210, 211 and Part11, Electronic Records, USP, ISO 13485 and 14644, and ISPE trends and guidelines. - CQE or CSSGB is a plus. - Experience with Trackwise and Documentum preferred.Additional InformationWe offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match, and wellness program.Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disabilities, or protected veteran status.

Keywords: Fresenius Kabi, Wilson , QUALITY ENGINEER (MQA), Engineering , Wilson, North Carolina

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