The Planet Group
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http://www.theplanetgroup.com
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LIMS/QMS Business Systems Analyst
201 Burlington Road Billerica, MA 01821 US
Posted: 11/21/2023
2023-11-21
2023-12-27
Employment Type:
Direct Hire/Perm
Job Category: LIMS
Job Number: 580646
Country: United States
Is job remote?: No
Job Description
Pharmaceutical Manufacturing organization located in northeastern Massachusetts, seeks an onsite LIMS/QMS Business Systems Analyst. The ideal person will be local or willing to relocate, with 5+ years of experience as a Business Analyst within QMSs. This person will also have worked on the administration of various QMS solutions to include one of the following: TrackWise, Veeva, Master Control, AsurX, or others. Additionally, this requires full SDLC implementation experience within QMS and LIMS, GxP validation, and some expertise with Chromatography Data Systems, ideally Empower. This opportunity requires US Citizen or Green Card work authorization and provides competitive base compensation, bonus, and benefits within an onsite role in northern Massachusetts for a local candidate or one willing to relocate.
Benefits
Responsibilities
Requirements
Benefits
- Competitive compensation
- Full Health Benefits
- 401K with a 4.5% client match
- Employee Stock Options within a growing organization that has experienced rapid stock growth.
- 15 days PTO; 4 additional floating holidays
- 6% annual performance-based bonus (this has increase annually)
- The ability to work on a full integration project, with additional exposure to various systems within a growing organization.
- A $5000 sign on bonus to be used on relocation if required.
Responsibilities
- Working with users to gather requirements, authoring these, and developing workflows, ensuring documentation throughout process pertaining to various QMSs (TrackWise, Veeva, MasterControl, AsurX), CDS Systems and LIMS.
- Serving as Business and Quality Systems Analyst to perform documentation and assist with a LIMS integration into Empower CDS.
- Assisting with the administration of QMS and CDS systems on an ongoing basis.
- Performing systems and IT set-up, troubleshooting issues, backing up systems, working on both upgrades and decommissioning of lab software and equipment.
- Helping to develop, execute, deploy, and support current quality technical solutions, while playing a key role in implementing new solutions to support the organization.
- Collaborating with Project Manager concerning various systems issues, concerns, scheduling of deliverables and completion of various tasks as needed.
- Working within GxP validated environment to contribute to the creation and execution of validation documents to include both IQ and OQs.
- Communicating and liaising regularly with multiple departments, all level of staff and users, and to ensure systems solutions are in place and understood accordingly.
- Working extensively within quality controls for manufacturing, both quality systems and document management, in addition to quality assurance, computer systems validation, validation of change controls, GxP, and Product Life Cycle Management.
Requirements
- US Citizen or Green Card Holder, located within the US.
- The ability to relocate near the client site in Massachusetts and work 100% onsite.
- Bachelor’s degree within biology, chemistry, or a related field.
- 5+ years’ experience as business analyst for quality manufacturing systems, LIMS and CDSs.
- Experience authoring and developing business requirements, workflows, and other documentation, while working directly with users.
- Prior experience serving as administrator for one of the following: TrackWise, Veeva, MasterControl, or AsurX, as well as a CDS.
- Ability and history of performing systems and IT set-up, troubleshooting issues, backing up systems, working on both upgrades and decommissioning of lab software/ equipment.
- GxP regulated environment and IQ and OQ expertise.
- Strong communication to ensure strong liaising with various users and departments.
- Manufacturing quality controls, quality assurance, change controls and systems validation, and product life cycle management experience.
- LabVantage LIMS, Empower CDS and/or NuGenesis ALM desired, but not required.
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