Quality Auditor

2 weeks ago

Atlanta, United States Integrated Resources, Inc Full time

Job Title: Quality Auditor - Scientific

Job Location: 100% REMOTE

Job Duration: 12+ months

Pay range: $ 31.82/hr. on W2

Job Description:

· Maintain an expert level of knowledge related to GMP requirements and industry trends as described in applicable worldwide regulations.

· Advise supported areas on requirements for all assigned project responsibilities as related to quality and communicate project status to management.

· Independently audit applicable regulatory filings. Ensure compliance with regulatory requirements. Work with areas to resolve any audit findings.

· Identify training needs and oversee, develop and/or conduct training or orientation sessions for internal staff and client groups as well as staying current with own training requirements.

· Identify need for and/or develop SOPs to ensure practices are accurately reflected.

· Represent GMPQ on inter-departmental and cross-functional teams, ensuring the flow of information and providing quality guidance.

· Independently prioritize activities in support of multiple projects.

· Support preparations for regulatory agency inspections.

Lead Auditor Requirements include:

· Foster Collaboration, Drive Results, Make Rapid Disciplined Decisions.

· Demonstrate excellent organization skills.

· Can effectively manage multiple projects, and delegate audits to support team/auditors.

· Request additional resources as necessary.

· Maintains positive working relationships within CMC auditing team and client areas.

· Share and apply lessons learned. Holds self and other accountable.

· Clear communication skills (express in a clear, concise manner).

· Demonstrate interpersonal skills to effectively lead an audit.

· Attend Project Team Meetings

· Act as a single point of contact .

· Keep close track of submission timelines and meets deadlines while still maintaining all audit goals.

· Identify and manage issues on a continuous basis (e.g. Unacceptable source documents, late submission of audit documents, delay in comments resolution that impacts submission time lines.)

· Provide guidance to the project teams in specific situations in terms of sources, audit maps, and workflows.

· Update the auditing team with changes in Submission Timelines, or other changes (Specifications, Methods, etc.)

· Prioritize audit sections based on CMC request.

· Effectively listen to the auditee and seek to understand differing perspectives to resolve audit issues. Specific and/or additional duties may include, but are not restricted to:

· Provide tracking, trending and metrics for GMPQ auditing activities, Provide technical guidance to senior management in evaluating systems/tools. Assist GMPQ staff and client areas with the technical aspects related to the use of electronic audit tools.

· Support Process Improvement initiatives for CMC client and auditing area.

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