JOB OBJECTIVE: Through their specified review, approval, and planning roles, QA Scientists apply their technical and quality system knowledge to assure internal and external customers that:
1. Promega catalog and custom products meet their predetermined performance, process, and system requirements for quality.
2. Major Process Changes and Hold disposition plans are implemented according to established procedures.
3. Participate in continuous improvement projects.
4. Technical literature (PPIs, labels, Technical Bulletins etc) are accurate and consistent.
5. Product performance claims and release criteria are based on objective data analysis.
1. Audit, data review, and approval of product batch records for the next manufacturing step or availability in inventory.
2. Review and approval of product Quality Control Protocols (QCP).
3. Review and approval of product labels (storage temperature, expiration dates).
4. Establish and approve shelf-life assignments for catalog and custom products in cooperation with Manufacturing, Marketing and R&D staff. This includes approval of study design, data review, and Process Change approval.
5. Review and approval of Technical Bulletins and Technical Manuals (performance and application claim accuracy and validity), including final release for publication.
6. Review and final approval of Promega Product Information (PPI) specification sheets and Certificates of Analysis; initiation, completion and signing of these documents as required for custom products and some catalog products.
7. Assessing the scope and inventory impact of nonconforming product situations; approving disposition plans of inventory product on Hold; assisting in the disposition planning for nonconforming product in branch inventories.
8. Review and approval of manufacturing and testing plans for specified custom products.
9. Assist in the preparation, review and approval of NPR documents.
10. Participate in the development of QC specifications and protocols that meet product and Quality System requirements.
11. Initiation, implementation, review and approval of Process Change Plans.
12. Reviewing, implementing, and participating in Corrective and Preventive Action plans.
13. Reviewing, implementing, and participating in product and process validation planning.
14. Reviewing, implementing, and participating in complaint investigation planning.
15. Participate in process mapping and SOP development as directed.
16. Write SOPs as assigned.
17. Participate in team meetings to resolve planning and technical issues. Propose constructive solutions to existing problems.
18. Evaluate risks based on customer, technical, business and regulatory factors, provide options and recommendations to mitigate risk.
19. Consider basic regulatory requirements in product or process issues.
20. Understands and complies with ethical, legal and regulatory requirements applicable to our business.
1. Organize, facilitate, or lead meetings to discuss review findings and planning issues.
2. Represent Promega in support of technical sales at national and international trade shows and exhibitions, or attend relevant scientific meetings as requested.
3. Contact customers directly about quality issues or questions as directed.
4. Organize and implement training programs in areas of expertise and experience.
1. B.S. degree with a minimum of 7 years work experience in a relevant industry with quality control, quality assurance, or manufacturing responsibilities.
2. Working knowledge and direct application experience of the requirements of quality assurance systems in a manufacturing and/or product development or process development environment.
3. Proficiency with basic word processing and spreadsheet software programs.
4. Ability to apply basic statistical concepts to analytical data, process validation, and Quality Assurance activities.
5. A demonstrable track record of process improvement and effective procedure writing and revision.
6. Able to develop concise, clear and accurate written communication.
7. Proven ability to work constructively with a broad range of people.
1. In-depth technical knowledge in genomics, protein analysis, or cellular analysis evidenced by peer-reviewed publications, qPCR and/or NGS experience preferred.
2. Work experience in Quality Assurance from a regulated industry.
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.
Diversity is important at Promega. We are proud to be an Equal Opportunity Employer, and make employment decisions without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, disability, or any other protected class.