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AMRI provides global contract research and manufacturing services to the pharmaceutical and biotechnology industries.

Director of Quality - 1002758
Description
DIRECTOR OF QUALITY in Grafton, WI
AMRI provides global contract research and manufacturing services to the pharmaceutical and biotechnology industries.
The Director of Quality is an integral part of the AMRI team, contributing to our success by overseeing the Quality Assurance, Quality Control, and Analytical Services Divisions of the AMRI-Grafton site. The position assures that all documentation, procedures and protocols comply with all GMP, GLP and, FDA guidelines. In addition, the position provides oversight of document control and implementation and enforcing compliance of all the site's Standard Operating Procedures and FDA guidelines through training, and internal audits. In it's oversight of Quality Control, the position ensures that any product produced by the site meets specifications for final release. This includes but is not limited method development, for Process Development Projects.
Join our talented workforce, where a commitment to excellence and a customer focused attitude is everything. We pursue excellence because our work has the power to improve patients' lives with the pharmaceuticals we develop and manufacture.
In this role, you will:
* Assist in cultivating good customer relations that foster profitable new and repeat business for the site
* Ensure that those products produced by the site meet customer and/or USP specifications prior to release.
* Assist in analytical determination of new product specification. This includes oversight of the development of new analytical procedures.
* Provide final projects analytical reports. Detect, recognize, and effectively communicate events that caused variation positive and negative in the successful completion of each project.
* Facilitate communication with customers and the site Quality department Ensure facility compliance with current good manufacturing practices and applicable regulatory guidelines.
* Detect, recognize and effectively communicate events in the external environment that could affect their department and the Company.
* Oversee the activities of the Quality Team
Qualifications
Qualifications and background to be successful in this role:
Required
* Thorough familiarity with all aspects of drug substance analysis (API identification, qualification, product specification, analytical techniques for product testing, and quality systems).
* Demonstrated understanding of Good Manufacturing Practices and the Food and Drug guidelines.
* Demonstrated ability to manage across departments to maximize productivity, reduce costs and increase profitability through leadership.
* Proven track record in identifying, devising a plan and, overcoming the most critical issues and problems.
* Demonstrated ability to proactively solve problems, meet customer needs, and lead by example.
Preferred
* Bachelor's or Master's degree in a natural sciences field such as Chemistry, Organic Chemistry, Biology or similar field
All interested applicants must apply online. AMRI is an Equal Opportunity Employer, we value diversity and inclusiveness. Minorities/females/veterans/individuals with disabilities/sexual orientation/gender identity are encouraged to apply.
Job
: Quality
Primary Location
: US-WI-Grafton
Organization
: AMRI Grafton
Schedule
: Full-time
Job Posting
: Jun 21, 2019, 10:09:21 AM

* Thorough familiarity with all aspects of drug substance analysis (API identification, qualification, product specification, analytical techniques for product testing, and quality systems). * Demonstrated understanding of Good Manufacturing Practices and the Food and Drug guidelines. * Demonstrated ability to manage across departments to maximize productivity, reduce costs and increase profitability through leadership. * Proven track record in identifying, devising a plan and, overcoming the most critical issues and problems. * Demonstrated ability to proactively solve problems, meet customer needs, and lead by example. Preferred * Bachelor's or Master's degree in a natural sciences field such as Chemistry, Organic Chemistry, Biology or similar field


Associated topics: design, engineering, manufacture, product, product manager, production, program manager, quality

* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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