Posted to MedZilla on 11/2/2017


Sunrise Systems Inc

US-DC, Scientist 17-12994-MZ


 
 

Title: Scientist

Location: Fort Washington, PA 19034

Duration: 12 Months contract

ID 17-12994

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 advance technical projects under the supervision of management.

· Maintains an environment of respect and teamwork with all coworkers.

Responsibilities:

· 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

Knowledge

· 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.

Requirements:

· 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

Contact

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

Email: [click here] | URL: www.sunrisesys.com


Visit Our Website

 
 


* If a direct employer requests that you go to their web site and complete your application there in order to be
  considered, please do so. Applications for all positions are subject to each employer's specific requirements.