Job Title- Documentation Specialist I (Administrative)
Location- Swift water, PA 18370 (Hybrid role)
Duration- 12+ Months contract with possible extension
Shift Timings- First Shift (EST)

Job Description:
Responsibilities
Assist with MTech Sample Plan: Assist in determining total number of samples based on protocols or notebook study; Prepare UPID based on protocol or notebook study sample requirements; Print move tickets for samples; Assist with sample transportation and delivery confirmation; Document sample execution and results in Lab ware
III. Document Coordination
The document coordinator's responsibility is to update and maintain a document list associated for MTech projects.
The number of documents managed will vary according to project load and can range from 700 to 1,200 documents. Current workload for 2020 is 1,100 documents.
The coordinator will compile document lists from individual project documentation list and publish weekly at a minimum.

Responsibilities
Maintain Project Documentation List
Forms Coordination
Update cGMP forms (1-2) per week as required for any updated MTech procedures
MTech document Periodic Review
Review Record and System (R&S) periodic review report (monthly) for MTech documents. Provide monthly update to MTech Platform heads
3. Laboratory Notebook Management
Managed and control of laboratory notebooks

Position Skill Set
1. Ability and willingness to meet the expected completion date
2. Communication with the specialist/executor and Group Lead is essential if unanticipated delays occur
3. Ensure accuracy of data pack prior to review with Group Leader and/or Specialist
4. Software Proficiency
a. MS Office 365 (Word, Excel, PowerPoint); ii. SharePoint iii. ProCal
b. Geode v. iLearn
c. Working knowledge of cGMP systems
d. SAP
e. Labware or similar sample management systems iv. eDoc/Geode- Documentation system

Qualifications:
1. HS Diploma, Associates, or bachelor's degree
2. Experience in the Pharmaceutical Industry

Note:

• Project support. Very administrative. MS office skills needed, excel, SharePoint, etc.
• Will be doing most of the sample coordination work and documentation work.
• Will be working with the group to make sure tasks are running on time.
• Pharma experience is also a plus.
• Primarily onsite. Chance of remote work, maybe once a week or once every two weeks type thing. Will be going from one building to another so will be a lot of walking.

Job Type: Contract

Salary: $20.00 - $26.00 per hour

Schedule:

• 5x8
• Day shift
• Monday to Friday

Ability to commute/relocate:

• Swiftwater, PA 18370: Reliably commute or planning to relocate before starting work (Required)

Education:

• High school or equivalent (Preferred)

Experience:

• pharmaceutical: 1 year (Preferred)

Work Location: One location

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