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(Pharmaceutical) Regulatory Licensing and Compliance Specialist

McGuff Family of Companies Orange County ,CA
  • Expired: over a month ago. Applications are no longer accepted.
Job Description

 

Intro

We are the first of the three companies located in Santa Ana, California. Specialized in wholesale distribution of medical drugs and products both inside the United States and internationally. Our goal is not just to sell products out of our warehouse. Sure, we can do that but we do so much more as well!

  • We ARE NOT those sales representatives that talk to our customers just to earn your business and then forget about them.
  • We ARE NOT order taking robots. – Although we can be if the customer needs to place an order real fast and shipped that same day!
  • We ARE NOT those people who have no idea how to use the products we sell.

Our purpose is to put Customer Service back into the Medical Products industry! Not in the sense that we are just “nice to talk to” on the phones, chat, or emails. Our purpose is to get to know you and your practice; we want to be your partner through all the crazy regulations within the modern medicine world.

Job Details

McGuff Company, Inc. currently has an opening for a Regulatory Specialist within our corporate office in Santa Ana, CA.

The Regulatory Specialist that will be responsible to coordinate, document, and create internal regulatory processes, such as internal audits, inspections, license renewals and registrations. Additionally, this position will be responsible to compile materials for submission to regulatory agencies such as California State Board of Pharmacy, National Association of State Boards of Pharmacy (NASBP), Food and Drug Administration (FDA), Drug Enforcement Administration (DEA).

Essential Functions and Duties shall include:

Responsible for coordinating and implementing activities related to future and ongoing regulatory compliance:

  • Regulatory compliance to healthcare law, regulations and policies.
  • Act as a company representative, developing and maintaining positive relationships with outside consultants and regulators through oral and written communications.
  • Maintain site registrations and licenses.
  • Assure semi-automated reports are provided to regulatory agencies on a daily, weekly, monthly basis
  • Develop/revise/implement departmental policies and procedure affecting regulatory and compliance.
  • Develop/revise/implement regulatory and compliance training to cross functional groups.
  • Preparation and submission of regulatory applications, as well as internal regulatory file documentation.
  • Participate in internal audit programs.
  • Participate in Corrective/Preventative Actions.
  • Participate and provide guidance for all aspects of company business that require regulatory insight and understanding.
  • Other duties as assigned.

Minimum and Preferred Qualifications shall include:

  • Education: Bachelor of Science/Arts degree, preferably in a scientific or technical discipline, or comparable additional experience.
  • RAPS Regulatory Affairs Certification (RAC-US, RAC-EU) is desirable.
  • General understanding of FDA regulations.
  • Must be comfortable with working in Microsoft Office Products, specifically Word and Excel
  • Must be able to type minimum of 40 WPM
  • General knowledge of federal and state business compliance requirements.
  • Computer literate and familiar with computerized documentation and database methods, tracking and control systems.
  • Ability to manage multiple projects.
  • Effective research and analytical skills.
  • Excellent written and oral communication, technical writing and editing skills.

What Is Expected of You:

  • Appropriate professional demeanor.
  • Acquire knowledge of and assure compliance to corporate policies and procedures.
  • Ability to work with others.
  • Excellent communication skills.
  • Work with all McGuff employees to foster and promote quality.
  • Excellent customer skills.
  • High regard for Trust, Integrity, Honesty, Ethics, and Safety in self and others.
  • High sense of responsibility, ownership of projects and accountability for work performed.
  • Capable of flexibility in work requirements/conditions and willingness to embrace change.
  • Results driven and hands on approach to completion of assigned tasks.

Why McGuff Company, Inc.?

The McGuff Company provides pharmaceuticals, medical devices, nutraceuticals, and services used daily by many leading healthcare professionals and organizations. We specialize in the distribution of 5,000 competitively priced medical products.

McGuff’s forty-one years of success is built on its innovative corporate culture and skilled employees working to understand customer needs and fulfilling them. McGuff customer support teams engage customers in a friendly non-competitive environment to offer best-of-class solutions to customer needs.

At McGuff, we offer excellent compensation and benefits programs that reflect our goal to be a competitive and supportive employer. We provide employees a comprehensive benefits package that includes medical, dental, vision, life insurance, paid sick leave and paid vacation time. 401K retirement plans are available and encouraged. McGuff is growing fast and new opportunities emerge every day. McGuff offers a supportive setting where employees can take control of their own career while enjoying the mentorship to develop new skills in an environment where you have an opportunity to thrive.

Want to learn more? Submit your resume now.

Company Description
We are a family company that has been in business for 35+ years located in Santa Ana California. We have three companies located in Southern California who are all seeking dedicated, hard working, candidates who bring a smile to work every day.

History:

Apollo 16 astronauts were walking on the moon when Gilbert J. McGuff (Gil), decided to supplement his income by supplying innovative medical products to Bariatric physicians and patients. Gil founded the McGuff Company (McGuff) in 1972 and became its sole proprietor. While working fulltime and managing McGuff after hours, Gil still found the time to instill an entrepreneurial spirit in all three of his sons. Each son eventually started his own business.

In 1979 Gil was approaching retirement and sold McGuff to his youngest son Ronald M. McGuff (Ron) who had been working for Procter & Gamble. Gil was hired by Ron as the first company employee and both Ron and Gil worked hard together to build upon McGuff’s early success as a nation-wide distributor of medical products. Ron’s first day working for the new McGuff was April 1st 1979.

A new direction was taken to align the company with the medical profession’s leading innovators in complementary medicine. Understanding the needs of these extraordinary physicians became paramount for McGuff. The McGuff team visited complementary physicians around the country to understand the unique therapies provided to patients. McGuff molded itself to provide these physicians with the unique products they desired.

McGuff was incorporated in 1982 and remains a family owned company.

McGuff developed associations with the industry’s leading manufacturers to bring quality drugs and medical devices at discounted prices to complementary physicians. McGuff developed a number of services and products to address specific needs of physicians and patients. Among these innovations; Ascorbic Acid injection with EDTA (replacing Monothioglycerol), Osmolarity Software, EDTA dose calculating software, IV administration sets with internal filters, and McGuff/physician computerized inventory control, etc.

The McGuff Company evolved to meet changing needs of complementary physicians and new therapies that they have developed. McGuff’s reputation for quality products, excellent customer support and regulatory integrity became known to a broad spectrum of physicians in the United States and around the world.

For more information about each of the specific companies please read below:

McGuff Pharmaceuticals, Inc.

McGuff, anticipating profound changes to the regulation of injectable drugs, chose to launch a second wholly owned subsidiary, McGuff Pharmaceuticals, Inc. (MPI) in 2002.

McGuff Pharmaceuticals, Inc. is a Food and Drug Administration inspected sterile fill manufacturer that maintains a tradition of quality and a core competency in both current Good Manufacturing Practices (cGMP), representing a unique combination for any pharmaceutical manufacturer.

MPI sustains McGuff’s efforts to assure physicians a steady supply of FDA approved drugs through its own drug development program. MPI also provides contract manufacturing organization (CMO) services, contract development and manufacturing organization (CDMO) services and is international in it scope.

MPI continues the McGuff tradition of providing personalized services, great customer care and the knowledge to be a valued member of any CMO or CDMO team.

MPI maintains offices in the United States and Canada

Website: www.mcguffpharmaceuticals.com

McGuff Family of Companies

Why Work Here?

Awesome CEO, Great Benefits, Room for growth

We are a family company that has been in business for 35+ years located in Santa Ana California. We have three companies located in Southern California who are all seeking dedicated, hard working, candidates who bring a smile to work every day. History: Apollo 16 astronauts were walking on the moon when Gilbert J. McGuff (Gil), decided to supplement his income by supplying innovative medical products to Bariatric physicians and patients. Gil founded the McGuff Company (McGuff) in 1972 and became its sole proprietor. While working fulltime and managing McGuff after hours, Gil still found the time to instill an entrepreneurial spirit in all three of his sons. Each son eventually started his own business. In 1979 Gil was approaching retirement and sold McGuff to his youngest son Ronald M. McGuff (Ron) who had been working for Procter & Gamble. Gil was hired by Ron as the first company employee and both Ron and Gil worked hard together to build upon McGuff’s early success as a nation-wide distributor of medical products. Ron’s first day working for the new McGuff was April 1st 1979. A new direction was taken to align the company with the medical profession’s leading innovators in complementary medicine. Understanding the needs of these extraordinary physicians became paramount for McGuff. The McGuff team visited complementary physicians around the country to understand the unique therapies provided to patients. McGuff molded itself to provide these physicians with the unique products they desired. McGuff was incorporated in 1982 and remains a family owned company. McGuff developed associations with the industry’s leading manufacturers to bring quality drugs and medical devices at discounted prices to complementary physicians. McGuff developed a number of services and products to address specific needs of physicians and patients. Among these innovations; Ascorbic Acid injection with EDTA (replacing Monothioglycerol), Osmolarity Software, EDTA dose calculating software, IV administration sets with internal filters, and McGuff/physician computerized inventory control, etc. The McGuff Company evolved to meet changing needs of complementary physicians and new therapies that they have developed. McGuff’s reputation for quality products, excellent customer support and regulatory integrity became known to a broad spectrum of physicians in the United States and around the world. For more information about each of the specific companies please read below: McGuff Pharmaceuticals, Inc. McGuff, anticipating profound changes to the regulation of injectable drugs, chose to launch a second wholly owned subsidiary, McGuff Pharmaceuticals, Inc. (MPI) in 2002. McGuff Pharmaceuticals, Inc. is a Food and Drug Administration inspected sterile fill manufacturer that maintains a tradition of quality and a core competency in both current Good Manufacturing Practices (cGMP), representing a unique combination for any pharmaceutical manufacturer. MPI sustains McGuff’s efforts to assure physicians a steady supply of FDA approved drugs through its own drug development program. MPI also provides contract manufacturing organization (CMO) services, contract development and manufacturing organization (CDMO) services and is international in it scope. MPI continues the McGuff tradition of providing personalized services, great customer care and the knowledge to be a valued member of any CMO or CDMO team. MPI maintains offices in the United States and Canada Website: www.mcguffpharmaceuticals.com

Address

2921 W. MacArthur Blvd.
Orange County, CA
USA

Website