Artech Information System LLC
Scientist II
Artech Information System LLC, Fort Washington, Pennsylvania, United States, 19034
LanceSoft is a nationally certified Minority Business Enterprise (MBE) that has established itself as a pioneer in providing highly scalable, cost-effective workforce solutions to a diverse set of customers across various industries in the United States. Headquartered in Virginia, LanceSoft currently operates out of several locations in the US and Canada.Job Description
Title: Scientist IILocation: Fort Washington, PADuration: 12 MonthsJob Description:II. Position Summary:Provides testing, technical and troubleshooting support in the QC laboratories. These functions include:Collection, processing, method development and testing of chemical components, bulk products, raw materials, packaging components, finished products, marketed product stability, in-process materials, scale up, validation and cleaning validations to conform with specifications and standard operating procedures (SOPs).Thorough knowledge of SOPs, USP and other applicable pharmacopeia.Possess foresight to recognize task needs and performs the trained task without the request of management.Reviews and/or writes the following documents: APR, SOPs, QSRs, Instrument qualification, protocol/report writing, trending and review/analysis of data.Performs statistical analysis in support of APRs, Stability, and Product Release.Complies with cGMPs, safety training and regulations.Performs more advanced technical projects under the supervision of management.Maintains an environment of respect and teamwork with all coworkers.III. Responsibilities:Ensure quality and compliance in all actions by:Attend GMP training on the schedule designated for the role and as appropriate for the role.Adhere to strict compliance with procedures applicable to the role.Exercise the highest level of integrity in the tasks performed.In a timely manner, identify, report, and seek correction for deviations noted in the workplace.Embrace a behavior of employee involvement and commitment to doing the job right the first time.Systems Knowledge:Be a Power User in the applicable systems and roles assigned.Trained to the role in which assigned as required for job function in the applicable systems.Utilize tools within MS Office and other systems to improve business effectiveness.Exposure to & working knowledge of electronic batch records and/or other automated processes/systems (labs).Working knowledge of SAP or ERP system; including other relevant systems per role.Product Knowledge:Understanding of product family, product size and put-up, and product characteristics (color, viscosity) associated with active and excipient.Training:Can act as SME and be a curriculum owner.Partner with training department to create training materials including curricula.Can act as qualified trainer in specific areas.Participate in all trainings and ensure all trainings are completed on-time.Investigations:Assists in gathering information and documentation as required.Participates in investigations as required.Compliance – Safety, GMP, Facilities:Provide support during regulatory inspections/audits as directed.Attend GMP training as scheduled.May provide statistical analysis in support of the APR and Stability processes.Adhere to strict compliance with procedures according to roles and responsibilities.Exercise the highest level of integrity in tasks performed.Documentation Management:Edit documentation (i.e. Standard Operating Procedures, work instructions) as necessary.Complete visual verification of the process and document these steps in the appropriate system.Document all activities per GMP requirements.Process Excellence, Lean, Continuous Improvement:Complete PE/Lean awareness training.Proactively identify opportunities for continuous improvement.Participate and lead continuous improvement implementations and kaizen events.Leadership:Job expert that less experienced personnel can go to for assistance.Provides leadership in absence of supervisors.Facilitates departmental meetings and may assist in the coordination of other scheduled meetings.IV. Requirements:Education: Bachelor’s Degree in Microbiology, Chemistry, Biology, Natural Science, Medical Technology, or related science is required.Experience:Minimum 2 years of GMP/GLP quality control lab experience in a pharmaceutical and/or OTC and/or regulated environment is required.Physical Demands: Capable of performing routine laboratory activities. Light to moderate lifting.Knowledge, Skills and Abilities: Basic knowledge/exposure of a LIMS system is preferred.
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Title: Scientist IILocation: Fort Washington, PADuration: 12 MonthsJob Description:II. Position Summary:Provides testing, technical and troubleshooting support in the QC laboratories. These functions include:Collection, processing, method development and testing of chemical components, bulk products, raw materials, packaging components, finished products, marketed product stability, in-process materials, scale up, validation and cleaning validations to conform with specifications and standard operating procedures (SOPs).Thorough knowledge of SOPs, USP and other applicable pharmacopeia.Possess foresight to recognize task needs and performs the trained task without the request of management.Reviews and/or writes the following documents: APR, SOPs, QSRs, Instrument qualification, protocol/report writing, trending and review/analysis of data.Performs statistical analysis in support of APRs, Stability, and Product Release.Complies with cGMPs, safety training and regulations.Performs more advanced technical projects under the supervision of management.Maintains an environment of respect and teamwork with all coworkers.III. Responsibilities:Ensure quality and compliance in all actions by:Attend GMP training on the schedule designated for the role and as appropriate for the role.Adhere to strict compliance with procedures applicable to the role.Exercise the highest level of integrity in the tasks performed.In a timely manner, identify, report, and seek correction for deviations noted in the workplace.Embrace a behavior of employee involvement and commitment to doing the job right the first time.Systems Knowledge:Be a Power User in the applicable systems and roles assigned.Trained to the role in which assigned as required for job function in the applicable systems.Utilize tools within MS Office and other systems to improve business effectiveness.Exposure to & working knowledge of electronic batch records and/or other automated processes/systems (labs).Working knowledge of SAP or ERP system; including other relevant systems per role.Product Knowledge:Understanding of product family, product size and put-up, and product characteristics (color, viscosity) associated with active and excipient.Training:Can act as SME and be a curriculum owner.Partner with training department to create training materials including curricula.Can act as qualified trainer in specific areas.Participate in all trainings and ensure all trainings are completed on-time.Investigations:Assists in gathering information and documentation as required.Participates in investigations as required.Compliance – Safety, GMP, Facilities:Provide support during regulatory inspections/audits as directed.Attend GMP training as scheduled.May provide statistical analysis in support of the APR and Stability processes.Adhere to strict compliance with procedures according to roles and responsibilities.Exercise the highest level of integrity in tasks performed.Documentation Management:Edit documentation (i.e. Standard Operating Procedures, work instructions) as necessary.Complete visual verification of the process and document these steps in the appropriate system.Document all activities per GMP requirements.Process Excellence, Lean, Continuous Improvement:Complete PE/Lean awareness training.Proactively identify opportunities for continuous improvement.Participate and lead continuous improvement implementations and kaizen events.Leadership:Job expert that less experienced personnel can go to for assistance.Provides leadership in absence of supervisors.Facilitates departmental meetings and may assist in the coordination of other scheduled meetings.IV. Requirements:Education: Bachelor’s Degree in Microbiology, Chemistry, Biology, Natural Science, Medical Technology, or related science is required.Experience:Minimum 2 years of GMP/GLP quality control lab experience in a pharmaceutical and/or OTC and/or regulated environment is required.Physical Demands: Capable of performing routine laboratory activities. Light to moderate lifting.Knowledge, Skills and Abilities: Basic knowledge/exposure of a LIMS system is preferred.
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