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Compliance Specialist II
Ref No.: 17-15203
Location: Allston, Massachusetts
Perform record review to ensure the compliance of manufacturing procedures to in-house specifications and government regulations on the manufacturing floor and ensuring on-the-floor presence of QA.
Conduct review of manufacturing processes to ensure compliance
Conduct review of testing results in support of release of intermediates
Provide compliance guidance to manufacturing support teams
Work closely with manufacturing and support groups to resolve all deviations within agreed timelines
Provide training to new employees
Additional Responsibility:
Participant in internal audits
Participant in Lean initiatives to improve Quality processes
Effectively interact on a cross functional basis providing QA guidance at the area level and escalate any issues to Management in a timely fashion
Ensure that department goals are achieved and on time Quality product is realized through execution of primary role in area of oversight (Batch Record Review, Deviation Management and/or Lot Disposition)
• Comply with the requirements of Sanofi Genzyme's health and safety program

Fully versed in CGMP, ICH, EMA and FDA rules, guidances and expectations
Experience in on the job training and authoring SOPs
Strong computer, verbal and written communication skills
Strong technical writing skills
Ability to gown and enter clean rooms
Require extended time in manufacturing areas