QMS Quality/Regulatory Consultant (Hybrid)(No H-1B or Corp to Corp)

Please note that this is a 5 Month Contract position and is Hybrid. 3 days onsite, can be onsite in Titusville, NJ or Horsham, PA.

No H-1B or Corp to Corp.

JOB DESCRIPTION:

Top 3 Skills:

• Data analytics exp
• Computer skills
• Background in Quality or Compliance

Top Skills:

• Bachelors degree is required
• Must have at least 2-5 years of relevant exp
• Must have Regulations knowledge
• DEA Regulations knowledge as well
• Experience with COMET system, or some type of Quality Management System (QMS)
• Must have prior Compliance experience

Education:

• BA/BS – Technical / Life Science
• Desirable: MA/MS/MBA – Business / Technical /Life Science
• Support Quality and Compliance Initiatives from Enterprise Quality and/or Global Business Quality

Essential knowledge and skills:

Knowledge

·         2-5 years’ experience in the Pharmaceutical or related industry;

·         Up-to-date knowledge of relevant pharmaceutical legislation and GMP / GDP;

·         Up-to-date knowledge of DEA regulations

·         Experience working in the quality organization.

Skills

·         Highly experienced in COMET system, generating query and report, and data analysis with excel spreadsheet

·         Results-driven leader who commits to stretch goals and delivers results.

·         Ability to build and nurture strong, positive relationships with business partners in IT,Manufacturing, Regulatory Affairs, Commercial and Quality functional groups.

·         Demonstrated understanding of regulatory requirements that impact Market Quality specifically, and client's more broadly. Experience in dealing with regulatory inspections and inspectional requirements

Core competencies required for this role:

·         Credo Values

·         Innovation

·         Masters Complexity

·         Customer/ Marketplace Focus

·         Independent Partnering

Essential duties and responsibilities:

·         Process Know Your Customer applications to purchase a specific product (50%)
Conduct routine data analysis for Suspicious Order Monitoring. (10%)

·         Process day-to-day product quality complaint (PQC) in quality system including evaluating PQC, assigning investigation, conducting investigation, writing investigation summary.

·         Proactively manage PQCs workflow with stakeholders to ensure all investigations are completed in a timely manner. (10%)

·         Process day-to-day quality events and change control records in COMET system (10%)

·         Coordinate documents and procedures in truVault system and any other document management system.(10%)

·         Coordinate internal and/or supplier audits including setting up logistic / preparation for the audits, drafting audit plan, supporting audit execution, coordinating audit response and CAPA with stakeholders, creating and documenting audit records in system. Ensure all audit commitments are delivered on time (10%)

Description:

The overall purpose of this position is to support quality activities for Commerical Quality including controlled substance requirements, quality complaints, change control, documentation, internal audit/ supplier audits. Adheres to environmental policy, procedures, and supports department environmental objectives.

 Candidates must provide their phone number. Job reference code is A5523.