Scientist II

Artech Information System LLC; Fort Washington (PA); On-site; USD 80,000 - 100,000; Full time

Job description

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 II

Location: Fort Washington, PA

Duration: 12 Months

Job 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.