Cell Therapies Manufacturing Facility – IT Business/Support Analyst – Operations
Full time, M-Fri
On-site in Cambridge, MA presence required.
Overview
The Cell Therapies Applications Support – IT Business/Support Analyst provides on-site operational support and business analysis for a fast-paced Cell Therapies manufacturing facility at a global Biopharmaceutical company based in Cambridge, MA. The position is responsible for supporting IT scientific laboratory operations and compliance and requires IT administration expertise, along with basic knowledge of the GMP validation.
Responsibilities
Serves as point of contact for applications analysis and support within the Cell Therapies Manufacturing group. Key tasks include:
- Support IT operations by performing business analysis for key systems and applications, including reviewing technical specifications, updating requirements, creating user requirements, and performing gap analyses intended to support system lifecycle management activities.
- Supporting compliance and maintenance of key GxP systems by performing various activities, such as but not limited to following up on audit trail reviews, Data Integrity, annual and periodic reviews, performing root cause analysis, and issue resolution for GxP systems.
- Performing effective cross functional collaboration with IT applications, Process Owners, QC/QA, network and vendor teams to ensure effective delivery and maintenance of key business systems in Cell Therapies.
- Support day to day operations per established procedures.
- Track maintain and own GxP lab IT systems inventory.
- Support IT validation activities.
- Drive CAPAs and Deviations as needed.
Required Education/Experience
- BS degree in Computer science or related discipline with experience
- Experience in FDA-regulated environment
- Familiarity with GAMP
Preferred Experience
- Familiarity with 21 CFR Part11
- Microsoft Technologies - .Net, MS Office, Share point.
- Computerized lab systems, MES systems, Vaisala, ERP and Off the Shelf applications
- QMS and DMS systems - TrackWise, BMRAM and Veeva Vault
- O/S knowledge – Windows
Job Types: Full-time, Contract
Pay: $60.00 - $75.00 per hour
Experience level:
Schedule:
- 8 hour shift
- Monday to Friday
Application Question(s):
- I have excellent client relationship management experience?
- I understand this position is initially a contract role with the potential to convert to a full-time position.
- Ideal answer: Yes
I have experience independently managing projects.
Experience:
- Windows: 1 year (Preferred)
- GAMP: 1 year (Required)
- FDA regulations: 1 year (Required)
- Help desk: 1 year (Required)
Ability to Commute:
Ability to Relocate:
- Cambridge, MA: Relocate before starting work (Required)
Work Location: In person