Verista's 600 experts team up with the world's most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world's most pressing healthcare challenges. Verista provides innovative solutions and services that empower informed decision-making and are the result of our significant investment in our people and our capabilities.
Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day.
Company Culture Guidelines & Values:
- We empower and support our colleagues
- We commit to client success at every turn
- We have the courage to do the right thing
- We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged.
- We constantly acquire new skills and learn from our experiences to enhance our collective expertise
CSV Engineer/Analyst Responsibilities:
- Must have CSV QA/quality experience; the ideal candidate will have performed the final QA signature on the entire SDLC documentation suite.
- Responsibilities include the following:
- Review and approve as the QA signatory all IT CSV project and system deliverables including but not limited to:
- Plans
- Requirements
- Specifications
- Test Protocols, Scripts and associated execution deliverables (such as test incident reports, etc.)
- Summary Reports
- Change Controls
- Provide CSV QA review of system operational and administration procedures to ensure they are adequate
- Document any findings of non-compliance
- Assist with strategy regarding remediation activities
- Assist with review of remediation activities
Requirements
- Must be willing to work onsite in Durham, NC
- Strong Data Integrity knowledge; knowledge of principles, how to apply them, and how to improve and implement data integrity.
- Demonstrated experience in BAS Desigo Migrations, LAT Sensors, and or AIMS Image Server replacement highly preferred
- Proficiency using PC and Microsoft Office tools
- Outgoing personality with strong ability to communicate effectively with peers in clear, concise terms
- Ability to work as part of a team
- Strong problem-solving and critical thinking skills
- Excellent organizational and time management skills
- Strong attention to detail
- GMP and Good Documentation Practice
- Intermediate skills with WORD (authoring/editing large technical documents with styles, tables, TOCs, track changes)
- Basic skills with EXCEL and PowerPoint
- Strong interpersonal skills and clear communication capabilities
- Experience with and tolerance for high levels of challenge and change
- Experience in GMP regulated environment
- Proven attention to detail and organization in project work
- Capable of working on assigned tasks without mentorship
Benefits
Why Choose Verista?
- High growth potential and fast-paced organization with a people-focused culture
- Competitive pay plus performance-based incentive programs
- Company-paid Life, Short-Term, and Long-Term Disability Insurance.
- Medical, Dental & Vision insurances
- FSA, DCARE, Commuter Benefits
- Supplemental Life, Hospital, Critical Illness and Legal Insurance
- Health Savings Account
- 401(k) Retirement Plan (Employer Matching benefit)
- Paid Time Off (Rollover Option) and Holidays
- As Needed Sick Time
- Tuition Reimbursement
- Team Social Activities (We have fun!)
- Employee Recognition
- Employee Referral Program
- Paid Parental Leave and Bereavement
For more information about our company, please visit us at Verista.com
For US geography, the salary range for this position is shown below. The actual salary is dependent upon a variety of job-related factors such as professional background, training, work experience, location, business needs, market demand, and competitive market practice. Therefore, in some circumstances, the actual salary could fall outside of this expected range. This salary range is subject to change and may be modified in the future.
$70,491 - $117,000
*Verista is an equal opportunity employer.
What We Do
Verista is a leading business and technology consultancy firm that provides systems, compliance, validation and quality solutions to life science companies - enabling them to improve health and improve lives. We help clients solve their most critical and complex challenges across the GxP lifecycle, from preclinical and clinical to commercialization, manufacturing and distribution – bringing together decades of knowledge, the most advanced engagement platforms and transformative technologies. This allows clients to benefit from the ease, efficiency and trust that results from working with one partner who excels across specialties. Verista’s clients trust the company’s 650+ experts to deliver consistent, safe, and high-quality results across the product development lifecycle. Verista is based in Fishers, Indiana, Wayne, Pennsylvania, Westford, Massachusetts, and San Mateo, California. For more information, visit www.verista.com
