Quality Auditor

On-Board Scientific is hiring a Quality Auditor - Scientific III (100% remote)

For immediate consideration please send your resume to

Subject Line: Position Title and State you are located

About Us:

On-Board Services, Incorporated is an on-site contract service provider for a local manufacturing entity providing full time positions to our employees. We offer benefits as well as 401k.

Position Details:

Position Type: 1-year contract with additional opportunity contingent upon performance and continued business need

Job Location: 100% remote

Shift: 1st shift

Compensation: $33.75 per hour (based on experience)

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 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 timelines.)

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

Qualifications:

B.S., M.S. and/or PhD. degree in an appropriate Science, Engineering discipline.

Required Experience and Skills: Minimum of 5-10 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, problem-solving, 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.

Preferred Experience and Skills:

Experience supporting Internal and/or external audits.

Please note that this role is 100% remote.

On-Board was founded in 1976 by Robert L. Wilson to provide Engineering and Design services to the chemical manufacturing industry. Today, On-Board is a thriving privately held family of companies with services including: Consulting, Professional Engineering, Industrial Maintenance and Facility Management, Contracted Manufacturing and Production Services, as well as Temporary Staffing and Recruiting throughout North America.

The On-Board Family of Companies conducts operations through its Corporate Headquarters located in East Windsor, NJ along with Regional Offices in New Castle, DE and Wake Forest, NC. On-Board's Mission is to provide "Flexible Service by applying the talents of our people, work processes and technology to meet our clients' expectations in a Safe, Responsible and Dependable manner."

On-Board Companies provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, religion, sex, national origin, age, disability or genetics.

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