Quality Assurance Senior Specialist

The Quality Assurance Senior Specialist will be primarily responsible for the review, approval and follow-up of implementation of GMP documents and records. The ideal candidate will have previous experience in this area in a GMP regulated industry and will have the ability to demonstrate flexibility in a fast-paced and changing environment.
Responsibilities:
oReview, edit and approve SOPs, GMP documents and records for compliance with company policies, procedures and regulatory requirements
oPerform routine follow-up on new and revised SOPs to confirm they are being followed as written
oProvide guidance and training on the interpretation and implementation of GMP regulations, company policies and procedures
oAssist with coordination, documentation and review of quality events as required
oAssist with tracking and reporting of quality metrics
oPerform other Quality Assurance duties as required
Qualifications:
oThorough working knowledge of GMP regulations and guidance documents
oExcellent interpersonal and organizational skills
oStrong attention to details
oHighly flexible to accommodate the needs of the organization
oAbility to prioritize tasks and meet timelines in a fast-paced environment
oFluent in Microsoft Word and Excel
oExperience using MasterControl is desirable
Education and
Experience:
oBachelor's degree in a life science field with 5 years of Quality Assurance experience in biologic therapeutic, pharmaceutical or related industry is strongly preferred

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