quality compliance analyst
quality compliance analyst.
indianapolis , indiana
posted 1 day ago
job detailssummary
$30 - $33.65 per hour
temporary
bachelor degree
category business and financial operations occupations
referenceAB4586526
job detailsOur client is looking to hire a regulatory Quality Compliance Auditor to support the companies global quality assurance policies and compliance. This is a primarily Remote position but you MUST be able to come into the Indianapolis office when audits are being run so MUST live a commutable distance from the office. This is a Temp To Hire opportunity. Qualifications:
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 appropriate regulatory knowledge to multiple scenarios
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.
salary: $30 - $33.65 per hourshift: Firstwork hours: 8 AM - 5 PMeducation: BachelorsResponsibilities
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.
Skills
Compliance
Quality Assurance
Regulatory Compliance - Other
Good Manufacturing Practice
Qualifications
Years of experience: 5 years
Experience level: Experienced
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+1 995 921 5414 (tel:+1 995 921 5414)
sravani.muthyala@randstadusa.com