Validation Specialist II

Company Description Artech is a global staffing and IT consulting company. We are constantly on the lookout for professionals to fulfill the staffing needs of our clients, and we currently have a job opening that may interest you. Below is a summary of the position.

Job Description

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

Qualifications

Refer Job Description Additional Information URGENT REQUIREMENT ! ! ! SWIFT ACTION FROM CLIENT EXPECTED