Quality Control Representative - Contractor - 7762

Discovery Solutions Published: November 28, 2017
Location
Job Type

Description

Quality Control Representative - Contractor
COMPANY:
Discovery Solutions is seeking job seekers for a contract position with one of our customers, Lilly, a leading pharmaceutical company headquartered in Indianapolis, IN.
LOCATION: Greenfield, IN 46140
DESCRIPTION:
Provide assistance and guidance in investigations, change proposals, procedure and manufacturing instruction revisions and validations. Assist with periodic self-inspections of the manufacturing area to assure GMP compliance and preparation for inspections by various regulatory agencies. Provide leadership in establishing and maintaining Quality Systems. Ensure appropriate execution of the Quality Systems to sustain a state of GMP compliance. Investigates customer complaints that are associated with the quality of products. Apply cGMP principles in all phases of product complaint investigations. Evaluate completed complaint investigations for accuracy and completeness prior to closure. Interpret and apply regulations, policies, and guidelines. Provide leadership for inspection readiness activities. Ensure that the site is in a constant state of inspection readiness.
Primary Position Responsibilities
: Support the development and creation of the PPM global & regional quality systems
: Interact collaboratively with PPM staff and QA groups to provide understanding and visibility of PPM oversight model and responsibilities
: Accountable to ensure routine, periodic reviews of artwork executed
: Review and approve launch related PPM
: Ensure compliance to PPM oversight model
: Create, manage and provide oversight of the PPM Quality assessment plans
: Support routine assessments for both internal and external partners
: Manage and provide oversight of the PPM Quality metrics
: Manage and provide oversight of the PPM Quality Q Plan
: Manage strategic regional project initiatives and drive process improvements
: Lead PPM Quality OE initiatives
: Review and approve launch related PPM
: Recognize and solve problems that occur regarding art work reviews
: Provide support and assistance for oversight of art studios and print vendors when needed.
: Participate on QA special project teams as required.
: Support and provide back-up for Regional PPM Quality Associates as needed for PPM investigations, launches and MAT
: Leverage supervision and other known expertise to resolve PPM issues and gain further knowledge of the PPM business
: Assure compliance to Quality agreement requirements
: Support PPM Quality project plans to meet business objectives and time lines
SHIFT: Monday-Friday 8:00AM-5:00 PM
EXPERIENCE:
: 3-5 years in any quality role; QA, QC, etc.
: Experience in a regulated industry is required.GMP is preferred, any other regulated environment would be considered, e.g., FDA.
: Excellent written, oral communication, interpersonal and organizational skills Excellent attention to detail and critical thinking skills
: Discipline to meet deadlines
EDUCATION: Bachelor's Degree

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