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Form of workJob Description
JOB SUMMARY
This position requires individual to have ability to perform wet chemistry and instrumentation testing as defined in Essential Job Functions and any other testing as assigned by the supervisor. Ability to understand the organization Stability Program and QMS Program. Ability to accept projects as assigned and ensuring on-time execution. The position requires individual to follow Standard Operating Procedure (SOP) and Good Laboratory Practices (GLP) as well as any applicable industry standards. Ability to understand company nonconformance SOP and assist with performing investigations to determine root cause under supervision. Ability to understand and perform calculations as required in BAP. Other essential job functions, responsibilities and requirements are listed below.
ESSENTIAL JOB FUNCTIONS- Capable of effective communication skills for interactions with laboratory colleagues, and colleagues from numerous functional areas.
- Capable of listening actively and readily assumes responsibility for actions.
- Ability to perform wet chemistry and instrumentation testing (HPLC, GC, IR, Karl Fisher, etc.) in a regulated environment by following procedures and/or USP testing procedures for finished products and raw materials samples.
- Ability to use Dishwasher, Balance Micropipette, LC, GC, IR, Auto-titrator, Oven, Viscometer, pH Meter.
- Ability to perform Water Determination, Visual Comparison, Package Integrity, Density, Refractive Index, pH, Organoleptic.
- Ability to understand "deals" associated with various markets. Ability to correctly associate "deals' to various PAR(s). Ability to read and understand USP-NF. Ability to understand and follow cGMP requirements.
- Ability to understand the organization Stability program/schedule for retrieval, testing and documentation of Monthly Samples. Ability to perform testing as assigned.
- Ability to use and have knowledge of the organization QMS program. Ability to launch packets in MC to revise PAR/RMS/BAP/FRM under minimum supervision. Ability to perform peer reviews or document reviews.
- Ability to accept projects as assigned. Ability to execute projects under supervision.
- Ability to understand and to perform calculations as required in BAPs and perform basic statistical calculations such as % Difference, Average, Standard Deviation, % RSD.
- Ability to understand the company nonconformance SOPs and assist with performing the investigations in determining root cause under supervision.
ADDITIONAL RESPONSIBILITIES
- 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.
- Performs and assumes other duties and responsibilities, as may be required by the Supervisor and/or Manager, Quality Control.
- Supports the Winner’s Circle and Blistex Quality System processes.
REQUIRED EDUCATION, EXPERIENCE AND SKILLS
- Bachelor's degree in Chemistry, Biology, or related scientific discipline with 0-1 years of applicable laboratory experience preferable in the cosmetics/pharmaceutical OTC industry.
- Complies with all safety standards while on Company premises and during performance of job functions.
- Computer literacy in a Windows environment is required. Familiarity with Excel, Word and/or Access Database is preferred.
- Must possess a good understanding of the safety standards and hazards associated with a Quality Control environment.
- High degree of familiarity with and ability to use office machines.
- Must be flexible to work 1st, 2nd, 3rd shift or a modified work shift, as departmental needs demand.
- Willingness to accept other duties, as assigned.
- Must be discreet with confidential information of which he/she has access.
- 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.
- Knowledge of computerized data acquisition and analysis systems, such as Waters Empower or PE Totalchrom is required.
- Must possess good oral and written communication skills in Business English (spelling, grammar, and punctuation, etc.).
PHYSICAL DEMANDS & ENVIRONMENT
- 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.
- This position will require the individual to lift up to 25 pounds 33 to 66% of the time.
- 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).
- 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.
- The noise level for this position will be moderate noise (Ex: Business office with typewriters and/or computer printers, light foot traffic).
- 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.
2nd Shift: 3:15 PM - 11:45 PM
