R&D Quality Specialist
This position is responsible for assisting with and coordinating the technology transfer and implementation of projects and technologies from the development groups to the plant manufacturing site both in-house and third party. Additionally, this role will be responsible for designing manufacturing processes for new or modified products to ensure robust and reliable product design and manufacturing processes for commercial scale. This role will act as the subject matter expert in tech transfer and actively collaborate with multiple teams (quality, regulatory, manufacturing, research & development, engineering, procurement etc.). This position will develop metrics to measure technology transfer success and completion.
ESSENTIAL FUNCTIONS AND BASIC DUTIES
• Oversee execution of product technology transfer ensuring they are completed on time, on budget and in a manner consistent with regulatory and quality requirements.
• Active member of the core team project teams as assigned.
• Communicate plant issues and tasks with the project team with respect to scaling up processes, new equipment and procedures, equipment and process validation, manufacturing of development, stability, and product validation batches.
• Coordinate the preparation of the manufacturing site for the manufacture of new products.
• Keep abreast of industry trends, developments, and opportunities, and be able to interpret how these impact the company, recognizing both threats and opportunities.
• Assess manufacturing processes using Failure Modes and Effects Analysis (FMEA) or other risk analysis method(s) and use the results to assist in the design of robust manufacturing processes.
• Assist in the preparation of master batch records and protocols for the manufacture of development, stability, and validation batches. Assist in translating development findings into manufacturing processes.
• Provide information and documentation needed for regulatory submissions or responses as required.
• Serve as the plant focal point for channeling all manufacturing related questions and issues for resolution between R&D and the site operations.
• Coordinate scale-up evaluation and support.
• Provide technical assessment of changes in manufacturing through appropriate review of documentation and testing results.
• Provide technical support for Investigations, Action Plans and Material Change Requests, etc.
• Develop and execute necessary investigative studies and validation protocols.
• Review various technology transfer documentation with regulatory and other appropriate groups.
• Coordinate project requirements with outside customers and vendors as required.
• Where gaps exists – develop action plans to improve.
• Focus responsibility for improving our technology transfer process
• Define successful completion of technology transfer through the development of meaningful metrics
EDUCATION/CERTIFICATION: A minimum of a BA/BS within a scientific discipline is required.
REQUIRED KNOWLEDGE: 8 years’ experience in product development, process scale-up, or technology transfer
EXPERIENCE REQUIRED: 4 plus years of applicable experience in QA/QC and/or regulatory affairs environment. A strong background in pharmaceutical and medical device product approvals is a must.
SKILLS/ABILITIES: • Ability to understand and scientifically interpret data utilizing analytical skills and practical experience
• Experience in an FDA & GMP regulated manufacturing environment
• Experience with Quality Control
• Experience validating tests and equipment
• Excellent interpersonal and communication skills (written and verbal)
NONE: No hazardous or significantly unpleasant conditions.
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.