Sequence Inc. is a total quality solutions provider to the Pharmaceutical, Biotech, and Medical Device industries. United with our clients, we strive to provide services that result in deliverables of the highest quality. Through our knowledge, experience, and integrity we offer a level of service that is unsurpassed industry-wide. We specialize in providing excellence in Automation & Control Systems Validation, Information Systems Validation, Software Configuration/Builds & Administration, Training, Equipment & Utility Qualification and Validation, Laboratory Instrument Qualification, Project Leadership, Auditing, SOP Development, Remediation, and much more.
At Sequence Inc., our employees embody core values that strengthen our culture and guide our overall success. The ability to maintain a selfless, humble Attitude creates a respectful environment where ideas are shared and valued. Our teams possess the technical proficiency to do the work and the Aptitude to continue learning, growing and stretching their potential. Our unstoppable Initiative and willingness to get things done using new ideas grows our capabilities and drives our future achievements.
We are currently looking for a LIMS Business Analyst/LIMS Admin (Mid to Senior Consultant Level) for our New England IT Quality Services Division. Candidates will need experience with a range of Laboratory Information Management Systems (LIMS) such as, but not limited to, Empower, LabWare, Labvantage. Applicants with a willingness to travel, temporarily relocate, or commute to client sites will be considered.
Essential Functions and Responsibilities
- Work collaboratively with Quality, Manufacturing, Vendor and IT at all levels to meet project deliverables and timelines
- Interact with the Laboratory operations group to support LIMS implementation and ongoing support for new module implementations and/or installation of new capabilities
- Work cross-functionally to integrate LIMS in a cGMP environment.
- Partner with IT and laboratory organizations, support users by responding to change requests and training needs
- Comply with Software Development Lifecycle (SDLC) and the company’s Computer Systems Validation (CSV) process and procedures
- Work collaboratively to manage, analyze and maintain complex master data and custom configuration in LIMS system
- Actively participate in all phases of application implementation, including ownership of key deliverables such as
- User Requirements Specifications
- Function Specification
- Design Specifications
- User acceptance testing
- Validation documentation
- Deployment support
- Assist in developing Standard Operating Procedures (SOPs) for global and local Laboratory Information Management (LIMS) Systems
- Identify and recommend areas of process improvement
- Perform knowledge transfer and provide ongoing leadership, to support project go-live and beyond, operations and support activities
- 5+ years’ experience analyzing business requirements and supporting information systems projects
- Experience in areas such as sampling, pharmaceutical quality control lab, laboratory data and reports (C of C, C of A), data management, change control, GLP/GMP and compliance.
- General understanding of pharmaceutical GMPs and 21CFR Part 11 regulations
- Excellent interpersonal, verbal and written communication skills including facilitating small group discussions and clarifying requirements
- Excellent technical writing experience in a regulatory environment, including experience in writing detailed requirements, user stories, business processes, technical specifications, test protocols and reports, for both custom and commercial off-the-shelf (COTS) systems
- Familiarity with Computer Systems Validation and GxP processes preferred
- Biotech/Life Science industry experience is strongly preferred
- Experience with LabVantage LIMS strongly preferred
- Experience in a manufacturing environment preferred. Experience with supporting a multi-site enterprise system with master data (LIMS, MES, PLM) preferred
- Comfortable in a fast-paced growing company with minimal direction and able to adjust workload based upon changing priorities
- Ability to work off-hours as needed
Our consultants must be knowledgeable and willing to go the extra mile in the service of a client, your success is our success. Here are some of the Benefits we offer:
- Competitive Pay
- Medical, Dental, and Vision Insurance
- Employer-paid long-term disability and short-term disability
- A $50,000 team member only life insurance & ADD policy
- 401k plan with employer contributions
- Generous PTO/ Time off
- Bonus Plan
- Reimbursable Expenses (Phone, Internet, and Mileage to Client Site)
We value our employees, and beyond the great pay and benefits we offer, we care most about offering opportunity. We are a rapidly growing consulting firm and would love to discuss the prospect of you joining our team. Sequence Inc. is proud to be an Equal Opportunity Employer, M/V/D/F. You will be considered for this position based upon your experience, without regard to race, color, religion, sex, national origin, age, sexual orientation, ancestry; marital, disabled or veteran status. Applicants for employment in the US must have work authorization that does not now or in the future require sponsorship of a visa for employment authorization in the United States and with Sequence.
Candidates who are currently employed by a client of Sequence or an affiliated Sequence business may not be eligible for consideration.