Compliance Analyst III/ Senior QA Compliance Auditor


Indianapolis, Indiana

a month ago

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Compliance Analyst III/ Senior QA Compliance Auditor
Indianapolis, Indiana

a month ago

Job Description

Job Title: Compliance Analyst III/ Senior QA Compliance Auditor
Location: Indianapolis, IN
Duration: 5 months
Shift & work Schedule: 1st Shift - 8:00 AM to 5:00 PM

The main function of a compliance analyst is to ensure the organizations operations and procedures meet government and industry compliance standards. A compliance analyst may research regulations and policies, communicate requirements, and apply for compliance certifications on behalf of the organization.
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)
  • of training in performance of audits (basic, intermediate, complex)
  • Participate (for multi-regulatory topics in area of expertise) global Delivery 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)  
  • Regulatory Compliance and Quality Assurance (RC&QA) responsibilities, as indicated in applicable controlled documents, are followed
  • Other duties as assigned by management.
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 scenario
  • 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

About Us: Established in 2004, SPECTRAFORCE® is one of the largest and fastest-growing diversity-owned staffing firms in the US. The growth of our company is a direct result of our global client service delivery model that is powered by our state-of-the-art A.I. proprietary talent acquisition platform, robust ISO 9001:2015/ISO 27001 certified processes, and strong and passionate client engaged teams. We have built our business by providing talent and project-based solutions, including Contingent, Permanent, and Statement of Work (SOW) services to over 140 clients in the US, Canada, Puerto Rico, Costa Rica, and India. Key industries that we service include Technology, Financial Services, Life Sciences, Healthcare, Telecom, Retail, Utilities and Transportation. SPECTRAFORCE is built on a concept of “human connection,” defined by our branding attitude of NEWJOBPHORIA®, which is the excitement of bringing joy and freedom to the work lifestyle so our people and clients can reach their highest potential. Learn more at:
Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees. Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program. SPECTRAFORCE provides unpaid leave as well as paid sick leave when required by law.

Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at if you require reasonable accommodation. 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $30.00/hr.

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