Details for the position are as follows:
- 14-month contract to start with the possibility of extension or conversion depending on performance and budget.
- Rate: $45-49 an hour.
- Location: Athens, GA
Job Description:
- 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.
- 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.
- Provides technical support for the investigation and resolution of deviations and atypical events by partnering with Quality Assurance to ensure consistent quality standards are maintained.
- Tracks deviations, events and key process parameters and provides reports to management on trending, and status as requested. Recommends corrective actions for any trends identified.
- Identifies and implements process improvements related to safety, environmental, quality, compliance, productivity, yield, and cost. Assure regulatory compliance and technical feasibility of proposed changes.
Required Skills:
- Bachelors degree required with a minimum of 2+ years of the below experience
- Experience with APIs (active pharmaceutical ingredients) required.
- GMP industry experience required.