Description

Position Summary:

• Responsible for compliance with internal procedures, local, state, and federal regulations and guidances at Nephron Pharmaceuticals Corporation and Nephron 503B Outsourcing Facility.

• Collaborate with all of Nephron’s departments to ensure supplier/vendor qualification, on-going monitoring, and approval as well as confirm material for intended use and suitability to ensure the company has the materials and services needed to conduct business.

• Demonstrate initiative, flexibility, and resourcefulness to support fast-changing program requirements.

• Assists with additional work duties or responsibilities as evident or required.

• Flexibility to work overtime and weekends, if necessary.

Primary Accountabilities:

NOTE: The primary accountabilities and the knowledge, skills and abilities listed below, are intended to describe the general content of and requirements for this position and are not intended to be an exhaustive statement of duties. Incumbents may perform all or most of the primary accountabilities listed. Specific tasks or responsibilities will be documented in the incumbents’ performance objectives as outlined by the incumbents’ immediate supervisor or manager.

• Oversee the Supplier Management team to ensure suppliers/vendors are qualified, evaluated, and monitored in accordance with governing procedures and work instructions.

• Responsible for reviewing, approving, or not approving the overall supplier qualification activities such as forms, questionnaires, performance evaluations, quality agreements, non-disclosure agreements, change notification agreements, supplier/vendor information, product/service information, certifications, FDA registration and inspection data, and all other required activities or documentation in accordance with governing procedures and work instructions.

• Review and approve supplier/vendor audit reports to ensure cGMP compliance; track responses for corrective and preventive actions, and close out audits.

• Review, perform, or approve supplier/vendor quality alerts and/or supplier CAPAs regarding quality, issues, resolution, and performance.

• Oversee spreadsheets to track and manage the Supplier Management Program’s workload.

• Coordinate, manage, and complete primary tasks and special projects with minimal oversight.

• Support and improve the Quality Management System.

• Assist in the management of initiatives, campaigns, and special projects.

• Elevate to leadership issues of concern and improvement opportunities identified.

• Develop and perform training for Supplier Management team.

• Devise and administer performance evaluations for Supplier Management team.

• Salary range: Based on experience.

• Hours of work: Monday thru Friday on an 8-hour shift, or as needed based on company demand.

Knowledge, Skills & Abilities:

• Preferred Bachelor of Arts or Science with 3 years of pharmaceutical or FDA regulated industry experience or other equivalent work experience.

• Specific expertise, skills and knowledge within GMP gained through education and experience.

• Proficient oral, written, and interpersonal skills with the ability to effectively communicate with all levels of employees, management, and suppliers/vendors.

• Strong attention to detail.

• Experienced in MS Word, Excel, Outlook, and PowerPoint.

• A broad perspective that aligns decisions to organizational objectives and long-term results of day-to-day activities.

• The ability to take strategic objectives and accept accountability to drive results through effective actions.

• The ability and willingness to change direction and focus to meet shifting organizational and business demands.

• The ability to set clear targets and use performance measures to assess risk and opportunities in order to effectively manage the assets of the business.

• The ability to create and contribute to an environment that values people, encourages trust, promotes teamwork, open communication, and provides participation, learning, feedback and recognition.

• The ability to effectively manage one’s self, demonstrates integrity, be productive under pressure, and achieve development goals.

• The ability to take strategic objectives and accept accountability, motivate and influence others, think globally, and leverage diversity.

• The ability to manage a multitude of resources and to be accurate and current with data and information.

• Position requires lifting (up to 40lbs), vision (20/20), standing (10%), sitting (40%), walking (50%), typing, talking and hearing.

EEO Statement:

Nephron is an equal employment opportunity employer and does not discriminate against employees or job applicants on the basis of race, religion, color, sex, sexual orientation, gender identity, age, national origin, disability, status as a protected veteran, pregnancy, marital status, genetic information, childbirth, medical needs arising from pregnancy and childbirth and related medical conditions, including lactation, or any other consideration made unlawful by applicable federal, state or local law.

Nephron Pharmaceuticals is a drug free workplace.