Quality Assurance Analyst

• Pharma Industry Experience Required

• BB72676 BB72670

  Titusville, NJ W2 Only $40 per hour
• 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 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 TechData is now a part of Quantive Intelligence, same people, expanded capabilities and we are proud to be an equal opportunity workplace and an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status.

Job Types:

Contract, Temporary Pay:

$40.00 per hour

Benefits:

Health insurance Application Question(s): What city and state do you currently reside in? What city and state do you reside in? Are you willing to accept $40 per hour for a hybrid contract?

Education:

Bachelor's (Required)

Experience:

Pharma:

1 year (Preferred)

Quality :

2 years (Required)

Regulations:

1 year (Required)

DEA Regulations:

1 year (Required)

COMET:

1 year (Preferred)

Quality Management System:

1 year (Required)

Compliance:

1 year (Required)

Data Analytics:

1 year (Required)

Pharma Industry:

1 year (Preferred)

Work Location:

In person