Quality Auditor - Scientific - III (Remote Role)
Pacer Staffing LLC
United States
![]()
![]()
![]()
See who Pacer Staffing LLC has hired for this role
Job Title: Quality Auditor - Scientific
Location: Remote
Duration: 12 Months (Possibility of extension)
Responsibilities
Location: Remote
Duration: 12 Months (Possibility of extension)
Responsibilities
- 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.
-
Seniority level
Mid-Senior level -
Employment type
Full-time -
Job function
Other -
Industries
Staffing and Recruiting
Referrals increase your chances of interviewing at Pacer Staffing LLC by 2x
See who you knowGet notified about new Quality Auditor jobs in United States.
Sign in to create job alertSimilar Searches
Looking for a job?
Visit the Career Advice Hub to see tips on interviewing and resume writing.
View Career Advice Hub