General Summary Description
Duties and Responsibilities
Trending of IP/FP and Analytical data for annual APRs
Trending of IP/FP and Analytical data in Minitab for CPV
Raw Material Trending and Reports
Prepare Annual Product Reviews
Handle Customer Inquiries
Training Functions (compliance wire, data entry, cGMP training)
Provide Regulatory support for ANDA CMC submissions
Data Entry
Provide Support for QA Matrix for Monthly Report
Issue Visitor Badges
Assists on Vendor and Outside Lab GMP Questionnaires
Coordinates BSE/TSE/Allergin /Residual Solvents Letters
Ensures all GMPs SOPs and protocols are followed
Perform additional duties required by Quality Assurance
Maintain Vendor Files and Prepare Compliance Reviews
Review of Raw Materials and Packaging Components
Review of Stability Data Packets
Review of Production Records
Filing
Direction Received
:
Initial direction for each job
Analytical Requirements
:
There is a choice of standard procedures
Decisions and Judgment
:
No authority to commit the organization in negotiations or with respect to finances
Initiative
:
Work is performed under direct supervision
Minimum Qualifications
A High School diploma/GED and 1 year of manufacturing or quality experience or equivalent combination of education and experience required.
Additional Requirements
Licenses/Certification
:
None
Special Requirements/ Skills
:
Moderate typing skills and ten-key by touch
Strong written, communication and problem solving skills
Ability to use general office equipment and general computer proficiency
Strong knowledge of Microsoft Office Suite (Word, Excel, Outlook)
Comfortable communicating with Federal Departments such as FDA
Knowledge of aseptic technique
Strong organization skills
Work Environment
:
Office environment
Qualified Applicants:
Please Contact:
Shari Rapposelli
Nostrum Laboratories, Inc.
1800 N. ping Ave.
Kansas City, MO 64120
Send resumes to HR Manager at Nostrum Labs, Inc. to
[email protected]