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:

1. Administer or provide support for a Quality System (example: Auditing (Internal/External/Customer, Annual Product Reviews, etc.)
   1. Maintain system electronic records
   2. Provide system metrics
   3. Follow up with owners of corresponding systems tasks/actions
   4. Hold review meetings on an appropriate basis to ensure timely completion and close.
2. Keep abreast of industry regulatory and cGMP trends. Stay informed of FDA, EU and ICH Guidelines.

Level II: (In addition to Level I requirements)

1. Independently administer a Quality System
2. Provide audit responses for audit observation pertaining to Quality Assurance system
3. Design and implement system improvements where opportunities are identified.

Level III: (In addition to Level II requirements)

1. Strong knowledge and understanding of Pharmaceutical Operations and Pharmaceutical Laboratory System
2. Manage and develop training programs independently to support area specific areas of expertise (APR, Audits, etc.)

QUALIFICATIONS

Level I:

1. Associate or Bachelor of Science in Chemistry, Life Science, Engineering or combination of training, education, and experience that is equivalent.
2. A minimum of 1 - 3 years pharmaceutical industry experience, including experience in Quality Assurance/Quality Control.
3. Working knowledge of Microsoft Office applications is required.
4. Excellent communication skills with colleagues, peers, and outside clients.
5. Attention to detail and capable of working independently

Level II: (In addition to Level I requirements)

1. A minimum of 5 years pharmaceutical industry experience, including experience in Quality Assurance or Quality Control.
2. Strong written and verbal communication skills, specifically in technical writing communications and oral presentations.
3. Capable of working independently based on regulatory requirements and corporate goals.
4. Strong knowledge of Data/Document Management Software applications

Level III: (In addition to Level II requirements)

1. 7+ years pharmaceutical industry experience, including experience in Quality Assurance and Quality Control.
2. Strong operational knowledge of all Pharmaceutical Quality System's.

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."