Compliance Specialist role is needed for a contract opportunity for Yoh Scientific's client located in New Brunswick, New Jersey.
The client is an American biotechnology company that discovers, develops and commercializes medicines for cancer and inflammatory disorders. If you meet the requirements, please send me your updated resume to .
"You must be eligible to work in the US without sponsorship."
Managing and coordinating activities related to GxP Enterprise Electronic Systems.
Leading, developing, and maintaining compliance activities across IT Enterprise Services supported regulated GPS applications.
Responsible for developing policies and procedures and coordinating all activities relevant between the Quality departments, IT validation and information technology in relation to implementation, maintenance and change control of computerized systems.
Provide quality/compliance oversight to all computer system validation related activities across the GPS enterprise. The manager will guide the staff to ensure a comprehensive System Development Lifecycle Methodology in alignment with GAMP 5 requirements.
Provide support services and governance to all supporting IT areas (GPS corporate and sites) to ensure global alignment to the computer compliance, global validation and change control standards.
Providing support to assigned Quality programs, such as Data Integrity Governance, Investigations, Global Quality Headquarters Training and other, as assigned Other responsibilities:
Evaluates and administers consultation on computer validation issues related to Quality related computer systems; works closely with Information Technology and Quality Operations on these related issues.
Ensures enterprise level metrics and tracking for Corporate Computer related CAPAs are maintained and reported appropriately.
Develops and implements policies and procedures related to Quality related system compliance activities related to Risk assessments, validation and the overall maintenance of system state of control.
Ensures compliance with all Company policies and procedures, including safety rules and regulations.
Partners with IT Validation to ensure risk assessments, incident management and oversight are aligned to corporate and data protection standards.
Performs related duties as assigned.
Bachelors degree in a related field from an accredited college or university, with a minimum of 5 years of related experience
21CFR11/ EU GMP Annex 11 and GAMP 5 standards
Data Integrity Guidance
Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), and other regulatory requirements
Project management practices and techniques
Software development life cycle
Computer hardware and software applications including Quality related computer systems, MS Office and MS Project
Principles and practices of computer compliance, validation and qualification
Knowledge of automated testing practices and tools a plus
External and internal inspections
Stakeholder management in a cross-functional organization
Reviewing user, functional and design specifications.
Reviewing and executing protocols and test scripts
Sampling, testing and measuring techniques.
Analyzing and troubleshooting problems, identifying solutions, recommending, and implementing methods, procedures and/or techniques for resolution.
Selecting, training, supervising and evaluating departmental personnel
Managing multiple projects, duties and tasks,
Communicating clearly and concisely, both orally and in writing.
Establishing and maintaining effective working relationships with those contacted in the course of work
Opportunity is Calling, Apply Now!
Recruiter: Kelly Hua
What's In It For You?
We welcome you to be a part of one of the largest global staffing companies to meet your career aspirations. Yoh's network of client companies has been employing professionals like you for over 65 years in the U.S., UK and Canada. Join Yoh's extensive talent community that will provide you with access to Yoh's vast network of opportunities and gain access to this exclusive opportunity available to you.
Medical, Dental & Vision Benefits
401K Retirement Saving Plan
Life & Disability Insurance
Direct Deposit & weekly ePayroll
Employee Discount Programs
Referral Bonus Programs
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Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Visit to contact us if you are an individual with a disability and require accommodation in the application process. Category: Marketing & Biz Dev , Keywords: Regulatory Compliance Specialist