What are the responsibilities and job description for the Quality Systems Specialist I position at Alvogen Inc.?
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 Manager Quality Systems.
RESPONSIBILITIES
Primary responsibilities of this role include the following:
Level I:
- Administer or provide support for a Quality System (example: CAPA, Change Control, Deviation, etc.)
- Maintain system electronic records
- Provide system metrics
- Follow up with owners of corresponding systems tasks/actions
- Hold review meetings on an appropriate basis to ensure timely completion and close.
- Keep abreast of industry regulatory and cGMP trends. Stay informed of FDA, EU and ICH Guidelines.
QUALIFICATIONS
Level I:
- Associate or Bachelor of Science in Chemistry, Life Science, Engineering or combination of training, education, and experience that is equivalent.
- A minimum of 1 - 3 years pharmaceutical industry experience, including experience in Quality Assurance/Quality Control.
- Working knowledge of Microsoft Office applications is required.
- Excellent communication skills with colleagues, peers, and outside clients.
- Attention to detail and capable of working independently
GMP DECISION-MAKING AUTHORITY
Level I:
Has authority to review and comment on GMP documentation
“An Equal Opportunity Employer, including disability/vets.”
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