Validation Specialist II
Job Title: Validation Specialist II
Location: Swiftwater, PA 18370
Duration: 07-12 Months
Duties:
Background:
The position is responsible for providing MTech Project Leaders with assistance in the management of samples collected and tested in support of studies for projects, non-commercial stability programs, manufacturing assistance, or investigations.
Scope of work:
- Typical scope of work required to support Pharmaceutical Technology department:
- Submit/approve Quality Control Independent Demand (QCID) for testing required for study. Manage SAP and LIMS to ensure Operations has the testing containers and documentation
- Monitor sample delivery and testing labs to ensure all samples are tested and results reported
- Manage LIMS approval process concurrent with Batch Record and MS approval
Deliverables:
- Ongoing deliverables in performance of this function.
- Approved QCID form
- Logistics for collections, movement, and chain of custody
- Sample delivery within current written instructions and guidelines
- Communication and delivery of sample results to support project team needs, commercial needs, and requirements for cGMP batch disposition.
Expectations:
- The background for this position is experience with company policies and applications.
- The expected capabilities for individuals receiving a contract to support this scope of work are as follows:
- Strong background in Microsoft Excel, MS Word, SAP, Labware, Batch Records, Operational SWIs, Governing site SOPs, Product Specifications, Documentum, and Trackwise.
- Strong communication and networking skills capable of delivery of information at all levels of the organization. Strong written skills.
- Successful completion of Training Module TMVALEXT007-001
Skills:
- MS Office with emphasis on Excel and Word
- E Doc
- Labware
- Trackwise
- 3-5 years working in a cGMP environment
Education:
- BS/BA in Life sciences or Associates with 5-7 years’ experience
Refer Job Description
URGENT REQUIREMENT ! ! ! SWIFT ACTION FROM CLIENT EXPECTED