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Documentation Specialist I-Admin Assistant
Ref No.: 15-03851
Location: Swiftwater,, Pennsylvania
To ensure compliance requirements and manufacturing/release schedules are met. This position will support Document Preparation/ Certification and Batch Record Review/ Disposition processes.
The incumbent will work independently with a level of authority for decision making that is necessary to drive process improvements, ensure ongoing compliance and current cGMPs.

Position Responsibilities:
Document Preparation/ Certification:

Prepare and certify working batch records required for Manufacturing to execute the batch

Batch Record Review/ Disposition:

Schedule, prioritize and prepare batches for disposition and distribution of final product to market Assemble the batch file dossier for review during Health Authority inspections Prepare the Certificate of Analysis which lists all acceptance criteria and test results related to a batch of product Perform cGMP reviews of media/reagent batch records Ensure lots are placed on hold within required time frame Prepare commodity verification sheets required for bulk manufacture

Compliance and Performance:

Ensure training is up to date to perform the designated cGMP activities and requirements for Health and Safety Record GMP data on documents right first time with >95% accuracy for completeness and compliance Meeting cycle time commitments per departmental agreements/commitments

Skills: Technical Competencies and Soft-Skills:

Previous experience is helpful in the following:

Ability to interact with cross-functional project teams Ability to handle multiple priorities and timelines to meet/exceed milestones Ability to negotiate and influence in a positive manner Knowledge of cGMPs (US, Canada, Japan, Europe) Experience with SAP, Quality eDoc, LabWare, TrackWise, Word, and Excel Strength in several LEAD Competences-Think Strategically, Lead Teams, Act for Change, Strive for Results, Cooperate Transversally, Commit to Customers, Make Decisions

Excellent skills in the following:

Communication
Interpersonal
Influencing
Organization
Leadership/Teamwork
Detail Oriented

Education: Basic Qualifications:

Bachelor's Degree
1+ years experience in a cGMP production and batch release facility