|Sunrise Systems Inc|
US-DC, Scientist 17-12994-MZ
Location: Fort Washington, PA 19034
Duration: 12 Months contract
· 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 advance technical projects under the supervision of management.
· Maintains an environment of respect and teamwork with all coworkers.
· Under limited supervision and in accordance with all applicable federal, state and local laws/regulations, the Companies’ policies, procedures and guidelines, this position:
· Ensure quality and compliance in all my actions by:
· Attend GMP training on the schedule designated for my role and as appropriate for my role
· Adhere to strict compliance with procedures applicable to my role.
· Exercise the highest level of integrity in the tasks that I perform
· In a timely and prompt manner, identify report and seek correction for deviations noted in my workplace.
· Embrace a behavior of employee involvement and commitment to doing the job right the first time
· Be a Power User in the applicable systems and roles assigned.
· 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
· Edits documentation (i.e. Standard Operating Procedures, work instructions) as necessary.
· Understanding of product family, product size and put-up, and product characteristics (color, viscosity) associated active and excipient.
· Provide support during regulatory inspections /audits as directed. Support may be in the form of scribes, runner, and document gathering.
· Strong working GMP knowledge. Communicates and identifies GMP gaps.
· Can participate in all types of audits & Inspections.
· Leads areas in ensuring all operations (processes) are completed in a compliant and safe manner.
· Wears the appropriate PPE when working in manufacturing and other hazardous working environments and advocates standards of safety.
· Bachelor’s Degree in Microbiology, Chemistry, Biology, Natural Science, Medical Technology, or related science is required
· Minimum 2 years of GMP/GLP quality control lab experience in a pharmaceutical and/or OTC and/or regulated environment is required.
· Capable of performing routine laboratory activities. Light to moderate lifting
· Basic knowledge/exposure of a LIMS system is preferred
Megha Verma | Team Lead- Talent Acquisition
Sunrise Systems Inc.
Transforming Business. Enhancing Careers
105 Fieldcrest Ave Suite# 504, Edison, NJ 08837 USA
Desk: (732) 272 0329
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