EDUCATION/CERTIFICATION: Bachelor degree in Chemistry, Pharmacy, Biology, Microbiology, Chemical Engineering (or equivalent). Advanced degree preferred.
REQUIRED KNOWLEDGE: Proficiency in Microsoft Office, Internet Browsers, and Adobe PDF applications.
EXPERIENCE REQUIRED: Minimum 7 years of experience in FDA regulated industries (pharmaceuticals and medical device) with 3 years in a cGMP audit role. Prefer a person which has both pharmaceutical and device experience.
Working knowledge of 21 CFR 210, 211, 820, ICH, ISO 9001, 13485, 22716
SKILLS/ABILITIES: Expert knowledge of the GMP Quality System and regulatory requirements in accordance with FDA regulations and ISO Standards. Must have excellent problem solving skills, based on science, facts, data and understanding of the regulatory requirements in complex and evolving environments. Must be able to apply sound risk management. Must have expertise in interdisciplinary areas of pharmaceutical sciences, operations, validation, analytical chemistry, microbiology, cGMPs and regulatory issues. Strong written and verbal communication skills with all organizational levels and external partners. Ability to troubleshoot complex problems.
NONE: No hazardous or significantly unpleasant conditions. Standard office environment. Must be able to sit in front of a computer for extended periods of time. Must be able to travel at least 50%.
INTENT AND FUNCTION OF JOB DESCRIPTIONS
Job descriptions assist organizations in ensuring that the hiring process is fairly administered and that qualified employees are selected. They are also essential to an effective appraisal system and related promotion, transfer, layoff, and termination decisions. Well-constructed job descriptions are an integral part of any effective compensation system.
All descriptions have been reviewed to ensure that only essential functions and basic duties have been included. Peripheral tasks, only incidentally related to each position, have been excluded. Requirements, skills, and abilities included have been determined to be the minimal standards required to successfully perform the positions. In no instance, however, should the duties, responsibilities, and requirements delineated be interpreted as all-inclusive. Additional functions and requirements may be assigned by supervisors as deemed appropriate.
In accordance with the Americans with Disabilities Act, it is possible that requirements may be modified to reasonably accommodate disabled individuals. However, no accommodations will be made which may pose serious health or safety risks to the employee or others or which impose undue hardships on the organization.
Job descriptions are not intended as and do not create employment contracts. The organization maintains its status as an at-will employer. Employees can be terminated for any reason not prohibited by law.
Nice-Pak Products, Inc. (NP) is the global developer, manufacturer and marketer of pre-moistened wipes for the consumer market, specializing in personal care, hygiene, household cleaning and disinfection products.