CMC Auditor
CMC Auditor
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
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 CMC Auditing on interdepartmental and crossfunctional teams ensuring the flow of information and providing quality guidance
Independently prioritize activities in support of multiple projects
Support preparations for regulatory agency inspections
Support other functional area and departmental priorities as needed
Lead Auditor Requirements include:
Foster collaboration drive results make rapid disciplined decisions
Demonstrate excellent organization skills
Effectively manage multiple projects and delegate audits to support team/auditors. Request additional resources as necessary.
Maintain positive working relationships within CMC Auditing team and client areas
Share and apply lessons learned
Hold 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 meet 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 CMC Auditing activities
Provide technical guidance to senior management in evaluating systems/tools
Assist CMC Auditing 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
Qualifications :
Education Minimum Requirement:
B.S. M.S. and/or PhD. degree in an appropriate Science Engineering discipline
Required Experience and Skills:
Minimum of 510 years experience with B.S./M.S. or five 5 years with PhD. Experience should be in pharmaceutical/biotechnology quality or compliance role
Extensive working knowledge of cGMPs and technical aspects of support area are required
Effective communication negotiation problemsolving and interpersonal skills with demonstrated project management abilities are necessary to perform job responsibilities
Previous experience required to perform job responsibilities may include:
Computer science IT quality assurance auditing or regulatory submission requirements
Additional Information :
Position is fulltime MondayFriday generally 8 a.m. 5 p.m. with overtime as needed. Candidates currently living within a commutable distance of West Point PA are encouraged to apply.
- Excellent full time benefits including comprehensive medical coverage dental and vision options
- Life and disability insurance
- 401(k) with company match
- Paid vacation and holidays
Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.
Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
