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