About the Company:
BD (Becton, Dickinson and Company) is a global medical technology company that is focused on improving drug delivery, enhancing the diagnosis of infectious diseases and cancers, and advancing drug discovery. BD develops, manufactures and sells medical supplies, devices, laboratory Instruments, antibodies, reagents and diagnostic products through its three segments: BD Medical, BD Diagnostics and BD Biosciences. It serves healthcare institutions, Life Science researchers, clinical laboratories, the pharmaceutical industry and the general public.
Job description:
Description Quality Scientist I – Microbiologist will support Miami’s Quality Control Laboratory by performing microbiological testing on raw materials, finished products and stability samples in order to meet increase of customer demand and achieve QC testing delivery goals.
- Performs microbiological testing on raw materials, finished products and stability samples according to applicable procedures.
- Collects environmental/utilities samples and perform analysis according to applicable site procedures. Maintain environmental trending data.
- Assists in completing project protocols, change notifications, deviation waivers and Quality Notifications with supervision.
- Performs assigned projects and tasks; compile testing data and review testing results.
- Maintains Microbiology Laboratory inventory. Order supplies, reagents and materials.
- Supports equipment maintenance activities.
- Understands lab safety and hazardous waste management.
- Cleans and maintains laboratory areas and equipment according to procedures.
- Supports investigations and implementation of corrective actions.
- Responsible for maintaining laboratory notebooks and records according to Good Documentation Practices.
- Performs Microbiology Lab activities as assigned by Quality Manager/Designee in order to achieve QC testing delivery goals.
- Maintains Microbiology Lab audit readiness.
Qualifications
- Minimum of BS degree in Life Sciences (Microbiology, Biochemistry, molecular biology,) with 2 years of Microbiology course work.
- Minimum of 2 years of experience in Microbiology lab in a Pharmaceutical, Biotech/ Aseptic filling environment, preferred.
- Strong knowledge of quality system regulations/requirements (i.e. ISO 9001:2000, 21 CFR Part 211/ 210, Part 601/610, Part 1271, Part 820 and cGMP/GLP and USP, EPA regulations).
- Good understanding of Cell culture systems, hybridomas, liquid and dehydrated media manufacturing process, aseptic and sterile fill process and systems.
- Experience with gram negative and gram positive, anaerobic bacteria, environmental fungi identification and testing methodologies.
- Experience with Bioburden/growth determination systems, aseptic methods and sterilization systems.
- Strong in application of technical principles, practices and procedures.
- Effective communication skills at all levels both written and verbal.
- Effective skills in analytical thinking and problem solving.
- Ability to perform multiple tasks and ability to effectively manage conflict.
- Ability to work in teams to obtain results, self-motivated/directed, ability to organize activities, minimal supervision required.
- Basic to intermediate proficiency in Microsoft Office and statistical programs (i.e. MiniTab, SAS).
- SAP experience preferred.
Working Conditions:
- Exposure to industrial machinery, sharp and moving parts, electrical and other energy sources.
- Personal Protective Equipment (PPE) required including but not limited to lab coats, hair / beard covers, shoe covers, gloves, ear protection, eye protection and specialized cleanroom suits and head coverings as required.
- Exposure to fumes and chemicals such as cleaners, inks, solvents, etc.
- Exposure to high frequency noise.
- Ability to lift up to 25 pounds repetitively, and up to 65 pounds non-repetitively.
How to Apply:
Apply online through company website or LinkedIn
Date Advertisement Posted - 29th December 2015
Job ID - QUA102HO
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