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| Company |
UDL Laboratories, Inc. |
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| Location |
Rockford, IL |
| Department |
Quality Assurance |
| Job Category |
SCIENTIFIC and Quality |
| Position Reference Code |
UDL_10_001502 |
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Mylan is a world leader in providing consumers with an extensive line of high-quality, affordable, and effective pharmaceutical products in a variety of traditional and innovative dosage forms.
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Opportunity Profile:
ESSENTIAL DUTIES AND RESPONSIBILITIES
1. Writing Validation and Addendum Validation Protocols, applying technical standards, principles, concepts, and techniques as applicable.
2. Reviewing, Writing, and Distributing Validation and Addendum Validation Reports.
3. Collecting, tabling and plotting generated data for the Validation and Addendum Validation Reports.
4. Interpreting the data generated for the Validation and Addendum Reports.
5. Interacting with other departments to facilitate obtaining the generated data for the Validation and Addendum Validation Reports and obtaining the required signatures in a timely manner.
6. Assisting with the Cleaning Validation Program, as needed.
7. Assisting with any other validations, as required.
8. Collecting and organizing FDA samples for storage.
9. Revise standard operating procedures as needed.
10. Creating new Standard Operating procedures as needed.
11. Auditing Equipment files making sure all qualifications are complete and accurate.
12. Auditing Quality Assurances (QA) Calibration program ensuring all paperwork is complete and accurate, and that all QA equipment in use is calibrated.
13. Coordinating and performing all aspects of the Validation process.
14. Assisting the QA Associate as needed with miscellaneous testing, review of calibrations, and other duties as required.
15. Performing other Duties as Assigned.
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Reporting
Structure:
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Qualifications:
QUALIFICATIONS
Must possess knowledge of cGMPs, SOPs, and FDA regulations. Must understand and adhere to company and department procedures and policies. Frequent use and application of technical standards, principles, theories, concepts, and techniques.
Must possess strong problem solving, communication, interpersonal and technical writing skills. Must be detail oriented and have the ability to multi task/ perform multiple projects/tasks simultaneously. Some mechanical aptitude.
Preferred in order to provide solutions for a variety of technical problems of moderate scope and complexity. Ability to read and interpret a variety of instructions furnished in written or oral, diagram or schedule form. Must possess computer skills and have a working knowledge of Microsoft Office Suite and Lotus Notes.
Minimum of 2 years experience with Bachelor of Science Degree in related scientific field preferred. However, a combination of experience and/or education will be taken into consideration. Ability to add, subtract, multiply, and divide. Ability to compute rate, ratio and percentages and to draw and interpret bar graphs.
PHYSICAL DEMANDS
Ability to sit or stand for extended periods of time. Lifting 25lbs. Ability to work flexible hours. Multiple working environments that include office environment as well as the production/manufacturing/warehouse environment.
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Educational
Requirements:
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Background
Requirements:
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At Mylan, we have an entrepreneurial spirit, where employees are challenged every day to exemplify our vision through their innovation, dedication, and integrity. We attempt to hire the best, and therefore, expect the best. If you are ready to meet this challenge, we invite you to join our team!
Mylan offers competitive salary, excellent benefits and an environment conducive to professional growth and advancement. Mylan is an Equal Opportunity Employer, M/F/D/V – Taking pride in diversity.
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