Process Specialist in Athens, GA

 Looking for a Specialist that would take the lead in investigations and provide guidance to operations

• Role will sit ONSITE in Athens, GA
• Will be a "backup" to the On-Call person
• Role is more "Process Specialist"
• The role is in the API Manufacturing, a Senior Role
• Bachelors degree required
• Must have exp in API bkg
• Will help support day-to-day operations
• Must have excellent Communication skills
• Must have excellent Time Management skills
• Must have GMP exp
• Will work with non-performance investigations, document investigations, and help provide corrective actions
• Will be working with Manufacturing Supervisors and Planners
• Should have Technical Writing exp
• Need someone who can learn the Science aspect of the job
• This is an Automated Process, should be familiar with those environments
• Must have at least 2 yrs exp

Job Duties:

• The Process Specialist is the technical expert who is responsible for providing technical support for the Active Pharmaceutical Ingredient (API), medical device raw material or medical device component manufacturing processes under limited direction of operations management.
• These responsibilities include providing technical expertise to ensure that atypical event and nonconformance investigations relating to production are completed in compliance with all applicable procedures and regulations, monitors and trends key process parameters, troubleshoots manufacturing problems as required and identifies and implements process improvements, supports capital projects, site wide initiatives or other projects as needed in the capacity of a project lead or a subject matter expert and conducts technical and validation studies.

Responsibilities:

• Provides primary (on floor) production support.
• Plan, prepare, issue, and control production schedule and material requirements to ensure control flow of approved material timed to meet production plan.
• Facilitate the implementation of the production plan.
• Takes corrective action for daily operational problems within the department.
• Act as subject matter expert (SME), providing guidance on deviations, investigations, and issues pertaining to quality of product.
• Study the need for improvements of existing processes, systems and equipment, and in cooperation with related departments, undertakes optimization to increase efficiency and quality and to reduce costs.
• Recommends and implements corrective/preventative measures aimed at improving compliance and reducing repeat occurrences.
• Follow up to determine if corrective actions adequately addressed root cause of NC event.

Minimum Qualification:

Education:

• High school education/GED plus two years formal technical education/training or; Equivalent
• Bachelor’s degree in science preferred.

Experience and Skills:

Required:

• Generally, 4-6 years of work experience in a chemical, pharmaceutical, medical device or similarly regulated manufacturing industry.
• Ability to learn and operate SAP Production, COMET, SUMMIT, to the level required.
• Technical understanding of at least one processing area.
• Ability to read, analyze and interpret procedure manuals, common scientific and technical journals, basic financial reports and legal documents, general business periodicals and government regulations.
• Ability to respond to sensitive inquiries and present information to Site Management, regulatory agencies and members of the business community.
• Ability to define problems, collect relevant data and information, establish facts, and draw valid conclusions as required.

Other Requirements:

• Regularly required to talk and hear, stand, walk, sit, use tactical sense, handle or feel and reach with hands and arms.
• Required to move around the manufacturing plant to perform on-site investigations.
• Needs to perform gowning procedures to work in manufacturing core.
• Specific vision abilities required by this job include close vision, distance vision, depth perception, and ability to adjust focus.
• Off-shift work may be required. On-call support may be required. Must be available for other duties as required.
• Travel Requirements: up to 10% domestic/international
• Needs to be mobile and able to independently transport themselves between various sites/locations, as dictated by the essential functions and responsibilities of the position.

Rangam Consultants is a minority, women-owned, disability workforce solutions global organization. Specialized in attracting and retaining talents globally for a rewarding career in IT, Engineering, Scientific, Clinical, Healthcare, Administrative, Finance, Business Management, and many more, while integrating veterans and individuals with disabilities into the workforce. Indeed, we connect career aspirants to relevant job opportunities, be it jobs in USA, UK, India, or Ireland. Also remote jobs, work-from-home jobs, or contract jobs in different verticals and industries.
Rangam strives to put job seekers first, giving them free access to search for jobs, post resumes, and research companies.Every day, we connect millions of people to new opportunities.