HireDiversity

Wilmington, DE, US

QA Specialist-6292130104

Description

Noramco, Inc., a member of the Johnson & Johnson family of companies, is currently recruiting for a Quality Assurance Specialist, located in Wilmington, Delaware.

Noramco, Inc. produces a variety of active pharmaceutical ingredients and is a major worldwide producer of medicinal analgesics, pharmaceutical intermediates and synthetic fine organic chemicals.

The Quality Assurance Specialist conducts and reports on inspections and audits of Noramco intra- and inter departments, vendors and other contract facilities subject to Noramco approval and inspection. In addition, this individual performs the Quality Assurance review and release of material to external customers.

The Quality Assurance Specialist reviews completed documentation (batch logs and shipments) for accuracy, completeness and adherence to cGMP's and releases materials for all shipments. Reviews QC data and prepares certificate of analysis for all materials shipped to customer. Conducts in-depth cGMP inspections of interdepartmental facilities and systems. Conducts cGMP audits of existing/potential analytical laboratories, raw material suppliers, existing/potential vendor facilities and contract manufacturers. Reports inspection findings to department and upper management in a timely fashion. Assists in conducting and developing site cGMP training. Assists in gathering data for GMP and customer audits. Reviews and updates, or acts as GMP consultant in the facilitation of, Standard Operating Procedures for Noramco of Delaware. Conducts and tracks quality investigations and process deviations. Monitors production deviations for trending purposes and Right First Time improvements. Member of specific project team or teams representing the Quality Services Department. Occasionally must move (push, pull, or turn) 15kg drums to get ready for shipment.

The Quality Assurance Specialist inspects final products. Utilizes SAP for posting stock, making usage decisions, changing batch status, recording final inspections, and running batch where used reports. Carries out duties in compliance with all state and federal regulations and guidelines including FDA, EPA, OSHA and DEA. Complies with all company and site policies and procedures where applicable. Successfully completes regulatory and job training requirements. Understands and performs duties with attention to quality, safety and environmental matters, including wearing appropriate personal protective equipment, recognizing, reporting and appropriately responding to hazards in the work area (spills/accidents/near misses), maintaining proper housekeeping at all times, plus all other relevant job requirements. Makes a positive contribution as demonstrated by making suggestions for improvement, and learning new skills, procedures and processes. Remains current in skills and industry trends. Is available on evenings and weekends as needed.

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Qualifications


A Bachelor's degree and a minimum of 2 years of work experience is required. Quality experience and/or training is preferred. Certified Quality Auditor certification is preferred. Strong technical writing skills and effective verbal communication skills are required. Proficiency in the Microsoft Office suite of products and the proven ability to effectively use software applications for data entry, data analysis, word processing, presentations, and calculations is required. The ability to work with others in a team environment is required. The ability to work in situations where speed and attention to detail are essential, performing a variety of tasks, is required. While performing the duties of this job, this individual will regularly be required to sit, stand, walk, talk, hear and reach with hands and arms. In addition, this individual will occasionally be required to move, push, pull, or turn 15kg drums. This position is located in Wilmington, Delaware.

BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.

Primary Location:North America-United States-Delaware-Wilmington
Organization: Noramco, Inc. (6109)