About the Company

EMD Serono, Inc., an affiliate of Merck KGaA, Darmstadt, Germany, is a leader in the US biopharmaceutical arena, integrating cutting-edge science with unparalleled patient support systems to improve people's lives. The company has strong market positions in neurodegenerative diseases, MS and endocrinology. EMD Serono is also a leader in fertility treatments. With a clear focus on the patient and a leadership presence in the biopharmaceutical industry, EMD Serono's US footprint continues to grow, with more than 1000 employees around the country and fully integrated commercial, clinical and research operations in the company's home state of Massachusetts.

This position will be for a limited duration of 6 months.

Description

This position will have responsibility for supporting the documentation program, training activities, facilities documentation, archiving, TrackWise administration and raw material specification sheets.

The person in this position has knowledge of commonly-used concepts, practices, and procedures within the field of his responsibilities. Relies on instructions and pre-established guidelines to perform the functions of the job. Works with supervision of more experienced QA personnel.

KEY TASKS & RESPONSIBILITIES

• Document Control support to include: Document processing (incorporating changes, routing for signatures, formatting, issuing final document for training, making document effective, dostribute approved documnet to all effected departments), production record issuance, change control system management, (issuing numbers, routing, tracking), and document archival system implementation.
• Training support to include: coordinating monthly GMP training in the PPL facility (identifying topics and trainers, communication of topics, providing presentation support), monitoring GMP training program to ensure compliance to established metrics, performing periodic audits on training binders, maintaining trainer binders and providing updates to area supervisors, performing GMP training. Acts as TrackWise coordinator/administrator and perform training on TrackWise for new employees.
• Facilities support to include: review of completed calibrations,review of critical systems and review of facilities SOP revisions.
• RM support to include: RM specification revision review and approval
• Manufacturing support to include: line clearance functions and real time audits.
• Project team support as required.
• Assist with internal and external audits as appropriate.
• Production Record review.
• Trending of Quality System Data.
• Quality System development.
• Documentation archiving, tracking and managing off site document list.