Sr. QA Scientist, Validation Promega
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JOB OBJECTIVE: Support validation activities required for QSR compliance.
1. Implement and Coordinate Validation Activities in Support of QSR-Compliant Manufacturing.
2. Establish procedures for validating equipment, processes and QC methods.
3. Create process maps for manufacturing and QC processes; utilize maps for validation planning.
4. Write Product Master Validation Plans, Qualification Protocols, and associated reports.
5. Review Product Master Validation Plans, Qualification Protocols, and associated reports.
6. Evaluate changes to validated processes.
7. Execute validation activities when appropriate.
a. Review and approve batch records, stability data and validation results to ensure that products meet requirements.
b. Review and approve technical literature content for accuracy and consistency.
c. Assess the scope and inventory impact of nonconforming product situations; approve disposition plans of inventory product on Hold and assist in the disposition planning for nonconforming product in branch inventories.
8. Serve as backup for QA Review function.
9. Review and approve manufacturing and testing plans for specified custom products.
10. Write SOPs as appropriate.
11. Evaluate risks based on customer, technical, business and regulatory factors, provide options and recommendations to mitigate risk.
12. Prepare and implement training plans in areas of expertise and experience.
13. Understand and comply with ethical, legal and regulatory requirements applicable to our business.
1. BS or higher degree in appropriate life science, chemistry, or engineering field.
2. Minimum of 6-10 years experience in the Pharmaceutical or Medical Device industry. Experience must be in manufacturing, process development, quality control or quality assurance.
3. Able to develop concise, clear written communication and presentations that contain both analysis and possible solutions.
4. Proven ability to work constructively with a broad range of people, including the ability to compromise and negotiate win-win solutions.
5. Proven ability to work constructively with a broad range of people, backgrounds, and functions.
6. Ability to perform analysis of complex problems or data requiring in-depth evaluation of various factors.
7. Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
8. Proficiency with basic word processing and spreadsheet software.
1. In-depth technical knowledge in genomics, protein analysis, or cellular analysis evidenced by peer-reviewed publications.
1. Visual acuity required for physical inspection of finished product and raw materials and accompanying documentation.
2. Ability to wear basic safety apparel (safety glasses or goggles, lab coats, protective gloves).
3. Ability to use computers in an interactive manner for extended periods of time.
Promega Corporation is an Affirmative Action/Equal Opportunity Employer
Madison, Wisconsin, United States
||2800 Woods Hollow Road |
Madison, WI 53711
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