Job Description

Position Description:

Job Title : Compliance Analyst III

Duration : 6+ months (Contract to Possible)

Location : Indianapolis, IN 46214, USA

Schedule : Monday through Friday 8:00am -5:00pm

Job Specifications

Job Title (if known): Senior QA Compliance Auditor

Business Title (if different): Sr QA Compl Auditor, GCP -CLS

Department Name: Regulatory Compliance & Quality Assurance

Job Function: Regulatory

Job Family: Quality Assurance

Business Unit: CORP- Quality Assurance

Reports to Title: Refer to organizational chart

* If this is a new role the Compensation team will assign the FLSA classification.

The statements below reflect the general responsibilities and requirements of the identified position

but may not describe all the work requirements that may be inherent in the job. It is the

responsibility of all employees to comply with all applicable regulations e.g. Good Clinical

Practice (GCP), Good Manufacturing Practice (GMP), and Good Laboratory Practice (GLP) in the

performance of their role.”

I. Job Summary:

A. Responsibilities/Duties

Indicate positions accountability

GLC/General Manager

Department Head/Function Lead

Manager of Managers

Manager

X Individual Contributor

FOR GLOBAL REWARDS USE ONLY: Template Revised – May 2018 Page 2 of 6

B. People Responsibilities:

Indicate the number of:

0 Direct Reports

0 Indirect Reports

C. Essential Job Duties:

• Conduct work as identified on the audit activity table (listing on table is not all inclusive but a

representative sample)

• Contributes to global QA policies on interpretation/ application of regulations

• Provide subject matter expertise to projects Support team in CAPA plan creation

• Hosts external audits/inspections e.g. regulatory inspections, strategic clients. Assists with the

facilitation of audit responses

• Supports the QA–to-QA relationship with key client(s)

• Delivery of training in performance of audits (basic, intermediate, complex)

• Participate (for multi-regulatory topics in area of expertise) global Quality initiative(s) aimed at

improving compliance and/or efficiency of the QA organization

• Supports the reporting of quality metrics and implementation of necessary corrective actions

and/or process improvements via appropriate forum (e.g. Monthly Reports, Site Quality

Review, Liaison meetings)

• Ensure Regulatory Compliance and Quality Assurance (RC&QA) responsibilities, as indicated

in applicable controlled documents, are followed

II. Experience:

Minimum Required:

• 6 years in regulatory environment (experience in GXP roles)

• Experience of industry quality systems/standards

• Excellent interpersonal/organizational skills, e.g. communication, decision making,

negotiating, problem solving

• Able to influence QA strategy systems/standards and ability to apply appropriate regulatory

knowledge to multiple scenarios

III. Education/Qualifications/Certifications and Licenses

Recommended:

• A minimum of a Bachelor’s Degree in a Pharmacy, Chemistry or Biology related discipline

• Postgraduate degree (MSC or equivalent) in science or management related discipline,

preferable

• Experience may be substituted for education.

IV. Competencies:

Information purposes only:

The Drug Development Competencies define the behaviors necessary for the organization to

achieve business outcomes. Please refer to the Drug Development Competencies for more

information about company-wide expectations for all employees.

EEO:

Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.

Thanks in advance for your time and consideration; please feel free to provide a current version of your resume. I look forward to hearing from you!

Job Tags

Similar Jobs