Quality Control Microbiologist II
: Job Details :

JOB SUMMARYThis position requires individual to master the performance of microbiological testing with little to no user errors as defined in Essential Job Functions and any other testing as assigned by the Supervisor/Manager. In addition, the incumbent must demonstrate good understanding of microbiological principles along with troubleshooting skills. Master ability to use all laboratory equipment and the principles behind the instrumentation. The incumbent requires a firm understanding and performance of calculation in BAP and perform statistical calculations as defined in required experience. A firm understanding of the Stability Program and the organization QMS Program is essential. Firm understanding of departmental projects and ability to manage tactical steps to plan, organize, move projects independently. Other essential job functions, responsibilities and requirements are listed below. ESSENTIAL JOB FUNCTIONS1. Must demonstrate effective communication skills for interactions with laboratory colleagues, project managers, and colleagues from numerous functional areas. 2. Must listen actively and readily assumes responsibility for actions. Capable of managing tactical steps to push projects forward. 3. Master the ability to perform various microbiological testing to support finished products or raw materials testing in a regulated environment with little to no user errors. For finished products or raw materials testing demonstrate a good understanding of the microbiology principles behind the testing conducted in the laboratory to aid in troubleshooting his/her own or colleagues testing issues. Gain expertise following USP or other pharmacopeia.4. Master ability to use the laboratory instrumentation and is able to understand the analytical principles behind the instrumentation. 5. Master ability to understand deals associated with various markets. Master ability to associate deals to PAR(s) with little to no errors. Master the ability to read and understand USP-NF. Master ability to understand cGMP requirements. 6. Firm understanding of the Stability program/schedule for retrieval, testing and documentation of Monthly samples. Master the ability to perform testing as assigned. Ability to pulls/Login Stability receipts. Ability to enter Data into Scientek.7. Firm understanding of the organization QMS for retrieval requirements, retrieve essential records, following record keeping procedures. Master the ability to launch packets to revise PAR/RMS/BAP/FRM was assigned. Master the ability to detect errors in peer reviews or document reviews. 8. Firm understanding of the departmental projects. Master the ability to plan, organize and complete projects independently.9. Firm understanding of the calculations as required in BAPs and compendial methods and in performing basic statistical calculations related to % Difference, Average, Standard Deviation, % RSD. Firm understanding of how to review peer data for calculation errors and how to interpret data under supervision. Assist in writing experimental testing plans to help with the investigational steps.10. Firm understanding of the requirements under laboratory assessment and investigation. Able to perform investigations, determining the root cause and the corrective actions with minimum supervision.ADDITIONAL RESPONSIBILITIES1. Performs special projects, as assigned by the Supervisor and/or Manager, Quality Control, which enhance and contribute to the growth of the Quality Control Department.2. Performs and assumes other duties and responsibilities, as may be required by the Supervisor and/or Manager, Quality Control.REQUIRED EDUCATION, EXPERIENCE AND SKILLS1. Bachelor's degree in Biology, or related scientific discipline with 1-3 years of applicable laboratory experience preferable in the cosmetics/pharmaceutical OTC industry.2. Master's degree in Biology, or related scientific discipline with 0-1 years of applicable laboratory experience preferable in the cosmetics/pharmaceutical OTC industry.3. Must possess good oral and written communication skills in Business English (spelling, grammar and punctuation, etc.).4. Complies with all safety standards while on Company premises and during performance of job functions.5. Computer literacy in a Windows environment is required. Familiarity with Excel, Word and/or Access Database is preferred.6. Must possess a good understanding of the safety standards and hazards associated with a Quality Control environment.7. High degree of familiarity with and ability to use office machines.8. Must be flexible to work 1st, 2nd, 3rd shift or a modified work shift, as departmental needs demand.9. Willingness to accept other duties, as assigned.10. Must be discreet with confidential information of which he/she has access.11. Must possess the ability to develop and maintain an effective working relationship with internal and external customers, function as a team player, accept constructive criticism from management, and comply with Company policies.PHYSICAL DEMANDS & ENVIRONMENT1. This position requires the individual to stand, walk, stoop, kneel, bend or crawl, reach with hands and arms overhead, and taste or smell 33 to 66% of the time. This position requires the individual to sit, talk or listen, and use hands to finger, handle or feel 66 to 100% of the time. This position requires the individual to climb or balance up to 33% of the time.2. This position will require the individual to lift up to 25 pounds 33 to 66% of the time.3. The vision requirements for this position includes close vision (clear vision at 20 inches or less), distance vision (clear vision of 20 feet or more), color vision (ability to identify and distinguish colors), peripheral vision (ability to see up, down, left or right while eyes are fixed on a given point), depth perception (3-dimensional vision, ability to judge distances and spatial relationships), and ability to adjust focus (ability to adjust the eye to bring an object into sharp focus).4. This position has exposure to wet, humid conditions (non-weather), work near moving mechanical parts or vibration, fumes or airborne particles, and toxic or caustic chemicals up to 33% of the time.5. The noise level for this position will be moderate noise (Ex: Business office with typewriters and/or computer printers, light foot traffic).6. The Personal Protective Equipment requirements that are used in this position is a hair net, beard net, safety glasses, cut resistant gloves, and fume hood.