Quality Packaging Specialist (cGMP)

Be a part of our success story! Delta Pharma is a leading National Clinical Research service and consulting firm. We strive to find the most talented and motivated professionals in the Clinical Research industry and place them in positions with our pharmaceutical clients that allow them to do the best work of their lives.

Delta Pharma is a member of the Vedior Group of companies, the third largest international staffing firm in the world, with over 2,300 offices in more than 43 countries.

We can provide Medical, Dental, 401K, and other benefits to our consultants as needed!

 

 

 



Job Title:

Packaging Quality Specialist

Reports To (Title):

Manager, Packaging QA

Function:

Quality Assurance

 

OBJECTIVES:

The Packaging Quality Specialist supports the Quality Assurance Department by directly interacting with internal customers and external suppliers to ensure the quality of marketed products and compliance with FDA regulatory requirements and Company quality expectations.  The Packaging Quality Specialist focuses on QA issues pertaining to commercial drug product packaging. 

 

ACCOUNTABILITIES: 

·  Assess commercial drug product lots for compliance with regulations (21 CFR Parts 210 and 211), cGMP requirements, supplier SOPs, Company SOPs, and Quality Agreement criteria.

·  Disposition Company commercial drug product for the U.S. marketplace.  Coordinate additional QA activities that are required to support the release of commercial drug product in order to meet trade and sample inventory demands.

·  Investigate product complaints through evaluation of batch record documentation and interactions with external supplier personnel.

·  Utilize Quality database to support product release and tracking, to assure current and accurate information is maintained.

·  Additional duties as assigned.

 





 

SCOPE OF SUPERVISION:





SUPERVISED NUMBER OF EMPLOYEES

 

Direct

In-Direct

Managers/Supervisors

0

0

Exempt/Professional/Technical

0

0

Non-Exempt

0

0

 

 

EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS: 

·  Bachelor’s Degree or High School diploma and 6 years of QA/QC work experience

·  Minimum 2 years of QA/QC experience in the pharmaceutical industry

·  Minimum 4 years experience in pharmaceutical manufacturing, packaging, or laboratory environment

·  Demonstrated teamwork, initiative, and problem solving skills

·  Strong oral/written communication skills

·  High attention to detail

 

 

LICENSES/CERTIFICATIONS:

·  None Required



 

PHYSICAL DEMANDS: 

·  Be seated at a desk and perform data review (on paper or a computer screen) for up to 8 hours per day

· Visits to third-party suppliers require exposure to pharmaceutical packaging facilities

 





TRAVEL REQUIREMENTS:None