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5580 - LabVantage/Empower Implementation Specialist/Senior Business Analyst

Boston, MA

Description

Verista’s 500 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

Overview:

We are seeking a skilled Senior Business Analyst with expertise in LabVantage LIMS and Empower to join our team. The successful candidate will be responsible for designing and implementing instrument interfaces between Empower and LabVantage LIMS. This role involves developing and executing validation protocols, maintaining system documentation, and collaborating with cross-functional teams to support laboratory operations in accordance with regulatory standards such as FDA 21 CFR Part 11 and GAMP 5.

Job Responsibilities:

  • Validation Planning and Execution: Develop, author, and execute validation deliverables for a LabVantage LIMS Instrument Interface Assessment. This role will require interfacing Empower with LabVantage LIMS and Instrument Interfaces with LabVantage LIMS and will include Validation Plans, User Requirements Specifications (URS), Functional Specifications (FS), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols
  • System Compliance: Ensure the Empower system meets regulatory requirements (e.g., 21 CFR Part 11, EU Annex 11) and adheres to Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP).
  • Documentation Management: Review, approve, and maintain validation documentation, Standard Operating Procedures (SOPs), and change control records related to the Empower system.
  • Risk Assessment: Conduct risk assessments to identify potential compliance gaps and implement mitigation strategies for the Empower system.
  • System Support: Provide technical support for Empower system users, troubleshoot issues, and coordinate with IT and vendor teams for system updates, patches, and enhancements.
  • Training: Train laboratory personnel and other stakeholders on the proper use of the Empower system in compliance with validated processes and regulatory guidelines.
  • Collaboration: Work closely with Quality Assurance (QA), IT, and laboratory teams to ensure seamless integration of Empower with laboratory instruments and other enterprise systems.
  • Change Management: Manage and document system changes, ensuring all modifications are validated and compliant with internal policies and regulatory standards.
  • Audits and Inspections: Support internal and external audits by providing validation evidence and system documentation for the Empower system.

 

Required Qualifications:

  • Education: Bachelor’s degree in Engineering, Computer Science, Life Sciences, or a related field
  • Experience:
    • Minimum of 7-10 years of experience in Computer System Validation (CSV) within a regulated industry (pharmaceutical, biotech, or medical device preferred)
    • Hands-on experience validating, supporting, and interfacing instruments between the LabVantage LIMS and Empower systems
  • Technical Skills:
    • Strong understanding of GAMP 5 methodology and FDA 21 CFR Part 11 compliance
    • Proficiency in developing and executing IQ/OQ/PQ protocols
    • Familiarity with laboratory workflows and integration of Empower with analytical instruments (e.g., HPLC, GC)
    • Knowledge of change control, deviation management, and CAPA processes
    • Understanding of data integrity principles and their application to laboratory systems
  • Soft Skills:
    • Excellent written and verbal communication skills for documentation and training purposes
    • Detail-oriented with strong organizational and problem-solving abilities
    • Ability to work independently and collaboratively in a team environment

 

Additional Requirements:

  • 3 days per week on-site requirement in Boston, MA

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.

*Verista is an equal opportunity employer.

National (US) Range

$80,465 - $136,225 USD

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

Verista collects and processes personal data in accordance with applicable data protection laws.  If you are a California Job Applicant, see the privacy notice for further details. 

For more information about our company, please visit us at Verista.com

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