W-2 Jobs Portal

  • W-2 Open Positions Need to be Filled Immediately. Consultant must be on our company payroll, Corp-to-Corp (C2C) is not allowed.
Candidates encouraged to apply directly using this portal. We do not accept resumes from other company/ third-party recruiters

Job Overview

  • Job ID:

    J36993

  • Specialized Area:

    QA

  • Job Title:

    Quality Analyst

  • Location:

    Parsippany-troy Hills,NJ

  • Duration:

    23 Months

  • Domain Exposure:

    Healthcare, Banking & Finance, Education, IT/Software

  • Work Authorization:

    US Citizen, Green Card, OPT-EAD, CPT, H-1B,
    H4-EAD, L2-EAD, GC-EAD

  • Client:

    To Be Discussed Later

  • Employment Type:

    W-2 (Consultant must be on our company payroll. C2C is not allowed)




Job Description

Job Duties: 


Ensure there is compliance at the Business Unit, supplier and warehouses. 
Manage change control for all GMP regulated products. 
Interpret GMP regulatory requirements and provide guidance for effective compliance, as well as providing EPD/NPD support for programs and projects, especially those requiring GMP compliance. 
Serve as the primary contact for any external or internal audit, with responsibility to implement any resulting corrective actions 
Develop, monitor, improve and maintain company procedures to ensure compliance with FDA Good Manufacturing Practice and GFSI/FSMA certification requirements 
Responsible for lot review/release activities for drug substances, drug products, and finished goods by Contract Manufacturing Organizations (CMOs). 
Assure the company, its affiliates and/or contractors associated with the manufacturing, packaging, labeling, testing and distribution of products used for investigational clinical trials through commercial phases comply with current Good Manufacturing Practices 
Manage change control for all GMP regulated products. 
Provide technical guidance and facilitate problem-solving methodologies regarding quality-related issues 

Requirements:

 
Degree in scientific or engineering field 
At least five years of work experience in manufacturing and or distribution pharmaceutical products in a professional / exempt level position in the areas of Quality Control, Quality Assurance, Compliance, Regulatory Affairs, or similar disciplines. Must include at least 5 years of such experience in US. 
Sound understanding of GMP's and FDA regulations especially for importing and distributing of Health and Food products. 
Sound understanding of Quality Systems. 
Must exhibit excellent communication and facilitation skills, both oral and written. 
Demonstrated proficiency in analytical and problem solving skills. 


Apply Now
Equal Opportunity Employer

ROBOTIC PROCESS AUTOMATION LLC is an equal opportunity employer inclusive of female, minority, disability and veterans, (M/F/D/V). Hiring, promotion, transfer, compensation, benefits, discipline, termination and all other employment decisions are made without regard to race, color, religion, sex, sexual orientation, gender identity, age, disability, national origin, citizenship/immigration status, veteran status or any other protected status. ROBOTIC PROCESS AUTOMATION LLC will not make any posting or employment decision that does not comply with applicable laws relating to labor and employment, equal opportunity, employment eligibility requirements or related matters. Nor will ROBOTIC PROCESS AUTOMATION LLC require in a posting or otherwise U.S. citizenship or lawful permanent residency in the U.S. as a condition of employment except as necessary to comply with law, regulation, executive order, or federal, state, or local government contract