Scientist III (4:00PM - 12:30AM)

Who we are
Fagron is the global market leader in pharmaceutical medicine, and its products are sold to more than 200,000 customers in over 60 countries. The goal of Fagron is: “Together we create the future of the personalized medicine”. Fagron, together with prescribers, pharmacists, and customers, strives to improve medications and help the patient. From our position as market leader, we act locally and think internationally.
About the job
SUMMARY · Coordinates and performs routine testing of in-process, finished product, raw material, and environmental monitoring per SOP, as needed. · Review work done by department staff for accuracy, completeness and conformance to specifications. · High level of understanding of Quality expectations and proactive thinking to address quality for documentation, investigations, and testing · Generates standard test solutions as required. · Performs microbial enumeration and gram staining, and growth promotion testing, as needed. · Understands department priorities and importance of planning ahead. · Keeps supervisory personnel informed of all relevant events impacting the operations and performance of the department including discrepancies and out of limit conditions. · Investigates nonconforming test results for product impact, root cause, and evaluates results to provide conclusions and appropriate corrective action. · Identifies additional testing to be performed to resolve these issues in a timely manner. · Investigates deviations from SOP requirements as directed by supervision for potential impact to product and materials and derives root cause of the incident. · Generates and updates new SOPs for microbiology test procedures. Updates and keeps others current. · Works with Lead/Senior Scientist, Supervisor or Manager in development and validation of new microbiological test methods. · Writes protocols for microbiology methods and production process validations. Participates in performing validation work. Performs studies needed to support incoming new products into the company. · Trains new department personnel in related SOPs. Assists in training manufacturing personnel in required aseptic technique and gowning technique as assigned by supervisor. · Maintains knowledge of cGMPs and GLPs. Ensures safety related polices are adhered and makes recommendations to enhance or improve safety policies. · Maintains knowledge of current compendial methods. · Coordinates special testing and project work as directed by management. · Maintains effective performance and constructive behavior during change. · Maintains a Quality Control function independently as assigned by the manager. · Performs other duties as assigned.
Set yourself apart
Experiences: · Bachelor of Science degree in a biological science with 9 years progressive laboratory experience. Equivalent combination of education and experience accepted. · Planning and organizational skills necessary for primary responsibilities. · Must successfully execute requirements to achieve ISO 5 environment gown certification as required by supervision. · Trained in cGMP at least 5 years. · Experience reading SOP, PBR, MBR, Job Aids and Training Modules is a plus. · Excellent attention to detail. · Superb verbal and written communication skills. · Proficiency in planning, organization, communicative, and teamwork skills are necessary for primary responsibilities and amongst coworkers. · Ability to work with minimal supervision and to take initiative is preferred. · Ability to excel in a fast-paced environment.
What's on offer?
We offer a dynamic environment where talent and ambition can develop to its fullest. We have an open and informal organization culture, where individuals need to have strong motivation and ability to work independently. Fagron is a widely expanding, international, professional, and ambitious pharmaceutical company with multiple growth opportunities. Job opportunity includes competitive salary, comprehensive benefits, performance package, and ability to be part of an international leader in an expanding industry.
Ready for the challenge?
Visit careers.fagron.com and discover your new career.
Who we are
Fagron is the global market leader in pharmaceutical medicine, and its products are sold to more than 200,000 customers in over 60 countries. The goal of Fagron is: “Together we create the future of the personalized medicine”. Fagron, together with prescribers, pharmacists, and customers, strives to improve medications and help the patient. From our position as market leader, we act locally and think internationally.
Job Reference: FA03538