At VTS we understand our strength is our people. We are looking for employees with great communication skills and strong technical skills. Teamwork is central to everything we do. Our employees are willing to relocate to any part of the United States.
VTS employees are creative, original, pragmatic and entrepreneurial finding new ways to increase the value of their client's extended enterprise, and managing information technology for business advantage. They are all talented professionals.
VTS employees work at various sites and our product implementation sites in which they are encouraged to explore their potential, take responsibility for their contribution. At the same time, they are team players, recognizing the value of their colleagues, and finding ways to inspire each other and their customers. We offer cutting edge technology and our primary focus is to develop your career at VTS.
To apply for one of our exciting career opportunities, send your resume, and your salary requirements to HR@vts-us.com
We offer employment to W2 hourly, Independent Contractors and full time salaried employees. Our employees can take advantage of our competitive benefits package that includes a health plan, 401k, provisions for vacation and holiday pay, and technical and professional training. Compensation is commensurate with experience. VTS is an equal opportunity employer.
Compliance/Validation Analyst (FDA-GMP) – Multiple openings
Validation Transcription Services Inc. in Princeton, NJ provides systems compliance solutions to FDA-regulated pharmaceutical, medical devices manufacturing, and biotech companies and is seeking Compliance/Validation Analysts (FDA-GMP) to design, analyze, and develop protocols for lab equipment and processes that produce pharmaceutical products which meet internal and FDA requirements. Individuals will apply advanced theoretical knowledge of natural sciences principles and concepts, as well as experience using standard occupational tools, to perform the following duties and responsibilities:
THIS POSITION DOES NOT SUPERVISE ANY OTHER PERSONNEL.
- Perform FDA compliance tasks including Good Manufacturing Practices (GMP), Good Automated Manufacturing Practices (GAMP), audits of validation processes, and documentation maintenance;
- Prepare validation plans for new or modified processes and systems for life sciences industry, conforming to 21 CFR Parts 210/211/820;
- Participate in the planning for all validation testing activities (IQ, OQ, PQ and UAT protocols) for regulatory systems;
- Analyze product characteristics and client validation procedures and requirements, and confer with management to determine validation objectives and standards;
- Use Document Management systems for tracking validation deliverables, developing defect reports, preparing Test Summary Reports and maintaining Requirements Traceability Matrix;
- Liaise with Quality Assurance Group regarding compliance documentation, data migration and validation results;
- Conduct validation tests of new or existing laboratory equipment and supporting systems, in accordance with internal protocols;
- Validate analytical lab instruments such as chromatography systems (liquid chromatography, gas chromatography), Empower and Soft Max Pro equipment;
- Validate systems that support enterprise resource planning, laboratory management, learning management, and safety management.
Master’s degree in Biology, Chemistry, Pharmacy or any STEM (Science, Technology, Engineering and Math) field of study that provided the required knowledge and abilities, plus 3 months of related experience that provided the required skills and abilities.
Qualified applicants must have demonstrable proficiency, knowledge and experience in the following:
- FDA guidance and pharmaceutical industry standards such as GAMP and regulations including predicate rules, Electronic Record Electronic Signatures and Quality System Regulations.
- Demonstrable understanding of life sciences standards and drug development process.
- Validation software such as Documentum, Enterprise Resource Planning (ERP), Learning Management, Laboratory Information Management System (LIMS), Clinical Trial Management System, or Safety Management System, Liquent Insight Publisher, Core Dossier using risk-based validation approach.
Any suitable combination of education, training or experience is acceptable. The term suitable, in this context, means compatibility with stated job academic level and experience requirements and ability to perform job duties. The applicant must provide verifiable references to support asserted facts.
- Job Site: Princeton, NJ
- No travel or telecommuting. Job duties are project-based and performed on long-term assignments at various unanticipated sites within the U.S. which may require relocation at the end of the project.
- Mail resume to: Validation Transcription Services, Inc., 12 Roszel Road, Suite C103, Princeton, NJ 08540, attn.: Santosh Enukonda
- No calls or emails. EOE.
- Must be legally authorized to work in the United States without sponsorship.