Novartis
Overview
QC Associate Scientist (GMP) role at Novartis. This is a temporary contractor opportunity. Responsibilities
Under general direction, perform testing and other activities in functions supporting the Quality Control department (Micro/EM, QC Bio-assay and raw materials, as appropriate). Perform Bio-Analytical testing such as qPCR, Flow Cytometry, ELISA, cell count, and cell viability. Perform micro/EM testing such as environmental monitoring, gram stain, sterility testing, endotoxin, and mycoplasma. Maintain controls and reference standards to support testing. Follow quality policies. Plan and schedule assigned activities. Generate trend reports. Review/approve data generated by other team members. Perform method qualification/optimization of methods as per appropriate protocols. Contribute to OOS/OOE investigations and deviation investigations. Support 5S and Lean projects. Identify potential improvements in project work. Interface with regulatory agencies during audits. Contribute to assigned projects. Knowledge of LabWare LIMS and/or other QC data systems. Maintain GMP/GLP quality systems. Provide coverage for all appropriate areas and test ng. Performs other job duties as assigned. Qualifications
Education:
BA or MS in chemistry, biochemistry, microbiology or other related science. Experience:
2 - 5 years of experience in the pharmaceutical, biologics, microbiology, sterile manufacture, or medical device industry. Knowledge of cGMP and an understanding of the concepts of GLP, good clinical practices and FDA guidelines, applicable state and foreign regulations, and standards routinely used in the industry (i.e., ANSI, ISO). Knowledge of microbiological and environmental monitoring, bioassay, and/or raw material test methods, as appropriate. Knowledge of LIMS systems. Ability to communicate clearly with a variety of individuals in various aspects of Novartis operations. Detail-oriented with expertise in problem solving and solid decision-making abilities. Strong interpersonal skills with a professional demeanor when interacting with Novartis personnel. Sound, practical and appropriate regulations with regards to Novartis. Strong written and verbal communication skills are essential. Competency Profile
Specific Professional Competencies: Indicate any other soft/technical/professional knowledge and skills requirements Thorough understanding of cGMP requirements Good communication and organizational skills Ensure customer satisfaction and react to customer requests Is seen as a competent team player Others Strong ability to work independently, compliantly and results driven. Strong analysis and decision-making skills surrounding documentation Pays attention to detail Able to proof work and identify non-standard format or wording, and errors within documents Location
Morris Plains, NJ (onsite) Shift
Week 1: Wed-Sat 3:30PM to 3:30AM; Week 2: Thu-Sat 3:30 PM to 3:30 AM Pay Rate
$30 - $35/hr based on experience and qualifications (W2 Only) Contract
6-month Benefits
Health, dental, vision, 401k Why Novartis
Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? EEO Statement
The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. Accommodation
If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to Magnit at directsourceproteam@prounlimited.com.
#J-18808-Ljbffr
QC Associate Scientist (GMP) role at Novartis. This is a temporary contractor opportunity. Responsibilities
Under general direction, perform testing and other activities in functions supporting the Quality Control department (Micro/EM, QC Bio-assay and raw materials, as appropriate). Perform Bio-Analytical testing such as qPCR, Flow Cytometry, ELISA, cell count, and cell viability. Perform micro/EM testing such as environmental monitoring, gram stain, sterility testing, endotoxin, and mycoplasma. Maintain controls and reference standards to support testing. Follow quality policies. Plan and schedule assigned activities. Generate trend reports. Review/approve data generated by other team members. Perform method qualification/optimization of methods as per appropriate protocols. Contribute to OOS/OOE investigations and deviation investigations. Support 5S and Lean projects. Identify potential improvements in project work. Interface with regulatory agencies during audits. Contribute to assigned projects. Knowledge of LabWare LIMS and/or other QC data systems. Maintain GMP/GLP quality systems. Provide coverage for all appropriate areas and test ng. Performs other job duties as assigned. Qualifications
Education:
BA or MS in chemistry, biochemistry, microbiology or other related science. Experience:
2 - 5 years of experience in the pharmaceutical, biologics, microbiology, sterile manufacture, or medical device industry. Knowledge of cGMP and an understanding of the concepts of GLP, good clinical practices and FDA guidelines, applicable state and foreign regulations, and standards routinely used in the industry (i.e., ANSI, ISO). Knowledge of microbiological and environmental monitoring, bioassay, and/or raw material test methods, as appropriate. Knowledge of LIMS systems. Ability to communicate clearly with a variety of individuals in various aspects of Novartis operations. Detail-oriented with expertise in problem solving and solid decision-making abilities. Strong interpersonal skills with a professional demeanor when interacting with Novartis personnel. Sound, practical and appropriate regulations with regards to Novartis. Strong written and verbal communication skills are essential. Competency Profile
Specific Professional Competencies: Indicate any other soft/technical/professional knowledge and skills requirements Thorough understanding of cGMP requirements Good communication and organizational skills Ensure customer satisfaction and react to customer requests Is seen as a competent team player Others Strong ability to work independently, compliantly and results driven. Strong analysis and decision-making skills surrounding documentation Pays attention to detail Able to proof work and identify non-standard format or wording, and errors within documents Location
Morris Plains, NJ (onsite) Shift
Week 1: Wed-Sat 3:30PM to 3:30AM; Week 2: Thu-Sat 3:30 PM to 3:30 AM Pay Rate
$30 - $35/hr based on experience and qualifications (W2 Only) Contract
6-month Benefits
Health, dental, vision, 401k Why Novartis
Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? EEO Statement
The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. Accommodation
If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to Magnit at directsourceproteam@prounlimited.com.
#J-18808-Ljbffr