No C2C Candidates allowed for this role due to client Limitation
Title : Quality Assurance Compliance Specialist (13485 ISO Certified)
Location : Indianapolis, Indiana, United States
Duration : 6+ Months
Shift : 1st Shift
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
- 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 scenarios
Recommended:
- A minimum of a Bachelor’s Degree in a Pharmacy, Chemistry or Biology related discipline
- Would be a 13485 ISO Certified Auditor.
- Postgraduate degree (MSC or equivalent) in science or management related discipline, preferable
- Experience may be substituted for education.
- 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.
- Tasks involve sitting in front of a terminal for many hours during the working day.
- Some overtime and weekend work may be required
“Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of – Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.”
