SUMMARY OF POSITION
The Quality Systems Specialist provides system administration and support of daily quality activities to ensure compliance with global regulatory requirements and guidelines (FDA, ICH, EU, WHO, etc.).
ORGANIZATION STRUCTURE
The Quality Systems Specialist reports to the Quality Assurance Manager.
RESPONSIBILITIES
Primary responsibilities of this role include the following:
Level I:
Level II: (In addition to Level I requirements)
Level III: (In addition to Level II requirements)
QUALIFICATIONS
Level I:
Level II: (In addition to Level I requirements)
Level III: (In addition to Level II requirements)
GMP DECISION-MAKING AUTHORITY
Level I:
Has authority to review and comment on GMP documentation
Level II: (In addition to Level I requirements)
Has authority to approve GMP documentation as designated by Quality Leadership, as needed.
Level III: (In addition to Level II requirements)
Has authority to approve GMP documentation as designated by Quality Leadership, as needed
This role will offer a base salary that is commensurate with experience and demonstrated skills in the $58,500.00 - $60,000.00 range.
“An Equal Opportunity Employer, including disability/vets.”
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Certification and Accreditation Process Skill
Compliance Management Skill
3205 St. Jude Medical, Cardiology Division, I, Elmira, NY
3205 St. Jude Medical, Cardiology Division, I, Elmira, NY