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