Customer Service Quality Systems and Documentation Specialist – Shire – Lexington, MA, USA
Working with Customer Service, Cold Chain Management, QA, and other Shire internal groups and external service providers, the Quality Systems and Documentation Specialist will be responsible for:
• Quality systems management
o Ensuring all quality systems are addressed and resolved in a timely manner to minimize impact on product supply
o Authoring deviations, CAPAs, and Change Controls
o Leading and managing deviations to closure within the established timelines. Conducting comprehensive investigations to identify root cause and implement corrective and preventative actions
• Documentation lead
o Developing and/or revising documentation (such as procedures, work instructions, job aids) applicable to the functional area
o Ensuring all documentation, both internally and with external partners, are up to date and reflect current processes
o Revising procedures as needed to maintain a robust process of supplying drug products to patients in a compliant manner
o Supporting training development and conducting training for Shire employees and/or external service providers
o Identifying gaps between current and desired processes, developing and implementing updates to procedures
Responsibilities:
50%:
Quality systems management (as described above)
50%:
Documentation lead (as described above)
Education & Experience Requirements:
• BA/BS degree
• 5+ yrs experience working in a cGMP environment
• Experience conducting investigations
• Working knowledge of logistics and distribution
• Experience with temperature sensitive logistics
• Proficient in writing and compiling concise documentation
• Experience working with TrackWise preferred
• Previous technical writing experience preferred
About Shire:
Shire’s Brave culture offers employees with diverse backgrounds the opportunity to enable those with life altering conditions to lead better lives.
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