What are the responsibilities and job description for the Quality Assurance Consultant position at Viltis?
Job Title: Quality Assurance GLP Consultant
Job Type: Contract (40 hours/week, hybrid onsite with a minimum of 3 days onsite per week)
Location: Hopewell, NJ
Job Overview:
We are seeking a QA GLP Consultant to support Good Laboratory Practice (GLP) compliance activities at our clients facility in Hopewell, NJ. This contract position requires non-clinical (GLP) experience. Candidates must have a strong understanding of 21 CFR Part 58 regulations and hands-on experience conducting phase audits, data audits, and facility audits. The consultant will also be responsible for answering GLP-related inquiries from lab personnel and providing guidance on HPLC-related questions from lab scientists.
Key Responsibilities:
- Ensure compliance with 21 CFR Part 58 and other applicable GLP regulations.
- Conduct phase audits, data audits, and facility audits to assess compliance and identify areas for improvement.
- Provide guidance and support to laboratory personnel, addressing regulatory and quality-related questions.
- Assist lab scientists with HPLC-related questions, troubleshooting issues, and ensuring compliance with GLP standards.
- Review and assess HPLC-related data and documentation for GLP compliance.
- Support the development and implementation of quality systems and audit procedures to maintain regulatory compliance.
- Collaborate with cross-functional teams to drive quality improvements and adherence to regulatory expectations.
Qualifications:
- Extensive experience in GLP QA auditing, with a strong understanding of 21 CFR Part 58.
- Hands-on experience with phase audits, data audits, and facility audits in a GLP environment.
- Proficiency in HPLC, including the ability to assist scientists with HPLC-related questions and troubleshooting.
- Strong analytical skills with the ability to interpret and apply regulatory requirements effectively.
- Excellent communication and interpersonal skills to interact with lab personnel and cross-functional teams.
- Ability to work onsite at least 3 days per week in Hopewell, NJ, with a 40-hour workweek.
Preferred Qualifications:
- Prior experience working in biotech, pharmaceutical, or contract research organizations (CROs) under GLP compliance.
- Experience with other analytical techniques and regulatory inspections is a plus.
This is an immediate contract opportunity with competitive compensation. If you have expertise in GLP compliance, auditing, and HPLC, we encourage you to apply.
This job description will be reviewed periodically and is subject to change by management.
The Company complies with all laws respecting equal employment opportunity and does not discriminate against applicants with regard to any protected characteristic as defined by federal, state, and local law, including disability/veteran status. This position may require you to work onsite or interact in person with customers of the Company and/or work onsite from time to time at the Company's facilities.
