RB Bio Analyst III BIO/LAL

• Follows standard operating procedures for testing product, buffer and WFI samples for bioburden and endotoxin
• Performs non-routine testing to support validations, new products and new raw materials
• Follows all good manufacturing practices and good laboratory practices, safety rules and department guidelines. Uses care and judgement in the use and handling of laboratory materials and equipment to maintain a complaint, safe, clean and orderly, working environment. Performs documentation and other duties according to cGMP rules and regulations. Maintains laboratory inventory.
• Collects, evaluates, records, and reports data, including: computer data entry.
• Actively participate in relevant sites inititatives such as: Behavior Based Safety and Cross Training, PSS.
• Maintains current training status for assigned SOPs, SOP revision training, GMP, HSES training. Maintain minimium eight-five percent (85%) qualification in Cirriculum.
• Performs 5S and safety audits of lab area and maintains lab in a complaint state.
• Performs other duties as assigned.

• Associate Degree in Biological Sciences, preferable Microbiology or equivalent combination of education and experience
• Minimium 1-3 years of experience in a pharmaceutical, clinical or Quality Control working environment
• Working knowledge, and understanding aspectic technique is essential
• Familiarity with a pharmacteuical, clinical of Quality Control working environment is desirable

• Read, write, speak and comprehend English in order to understand written and vertbal instructions, SOPs, etc
• Follow directions, written or verbal and be proficient in math.
• Acceptable attendance and performance.
• Work weekends, holidays, and overtime as required.
• Work independently and self-directed
• Strong Attention to detail
• Working knowledge and understanding of cGMP and global regulatory compliance
• Strong computer skills
• Familiarities with Lab management systems (LIMS) and Mobile Data Acquisition System (MODA)
• Follow all data integrity rules
• Follow Standard Operating Procedures (SOPs)
• Ability to multi-talk and good adaptability to changing business requirement in dynamic corporate environment

• Must be able to work at biological safety cabinet for up to 2-3 hours test periods.
• Must have good manual dexterity for the accurate operation of pipettors.
• Must not have unusal sensivitiy to typical lab chemicals or globes (sanitizing agents)
• Must have good visual acuity and color perception in order to enumerate microbial growth and testing using a microtiter plate.
• Must be able to withstand frequent repetitive movement, stooping, crouching, kneeling, climbing and sitting.
• Must be able to wear protective clothing as required
• Must meet Occupational Demands/ Physical Requirements checklist.
• Hepatitis B vaccine recommend.

Bayer