NOTES :

• Role will be HYBRID, 3 days onsite, can be onsite in Titusville, NJ or Horsham, PA
• Bachelors degree is required
• Must have at least 2-5 years of relevant exp
• Must have Regulations knowledge
• DEA Regulations knowledge as well
• Exp with COMET system, or some type of Quality Mgmt System (QMS)
• Must have prior Compliance exp

Top 3 Skills:

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

Quality Analyst

• 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.

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%)

Required:

• BA/BS – Technical / Life Science

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