Quality Assurance Compliance Specialist

1 week ago


Indianapolis, United States Mindlance Full time

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.”



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