Quality assurance compliance analyst

Our client is looking to hire a regulatory Quality Assurance Compliance Analyst 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 apply appropriate regulatory knowledge to multiple scenarios

Education/Qualifications/Certifications and Licenses

• 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: $36 – $38.4 per hour
shift: First
work hours: 8 AM – 5 PM
education: Bachelors

Responsibilities

• 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

Qualifications

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Pay offered to a successful candidate will be based on several factors including the candidate’s education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).

This posting is open for thirty (30) days.