Sr QA Scientist 1

at Promega
Location 2800 Woods Hollow Rd, Fitchburg, WI
Date Posted September 23, 2020
Category Bioscience
Job Type Full-time
Address 2800 Woods Hollow Rd

Description

**This position will be supporting Genetic Identity and DNA Amplification products.

 

JOB OBJECTIVE: Through their specified review, approval, and planning roles, QA Senior Scientists assure external customers that:

a. Promega catalog and custom products meet their predetermined performance, process, and system requirements for quality.

b. Labeling and technical literature are accurate and consistent.

c. Major changes are implemented according to the principles of quality planning.

And support internal customers by:

a. Providing guidance on Quality System requirements (non-conforming product, documentation, change management, stability testing etc.).

b. Establishing technical standards for product performance and quality in cooperation with Manufacturing and Marketing staff.

c. Providing input and support in experimental design and data analysis as part of new product development, process improvements, expiration dating and troubleshooting activities.

ESSENTIAL DUTIES:

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. Follow Quality System procedures that define QA-specific or shared processes.

8. 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.

9. Review and approval of manufacturing and testing plans for specified custom products.

10. Assist in the preparation of and review Quality Planning Checklists for New Products and for other projects.

11. Assist in the preparation, review and approval of NPR documents.

12. Participate in the development of QC specifications and protocols that meet support product and Quality System requirements.

13. Initiation, implementation, review and approval of Process Change Plans.

14. Reviewing, implementing, and participating in Corrective and Preventive Action plans.

15. Reviewing, implementing, and participating in product and process validation planning.

16. Reviewing, implementing, and participating in complaint investigation planning.

17. Participate in process mapping and SOP development as directed.

18. Write SOPs as appropriate.

19. Participate in team meetings to resolve planning and technical issues. Negotiate constructive solutions to existing problems.

20. Help others understand and plan for the impact of changes on related processes.

21. Evaluate risks based on customer, technical, business and regulatory factors, provide options and recommendations to mitigate risk.

22. Understands and complies with ethical, legal and regulatory requirements applicable to our business.

OCCASIONAL DUTIES:

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. Participate in training programs in areas of expertise and experience.

MANDATORY QUALIFICATIONS:

1. Graduate degree in appropriate life science, chemistry, or biochemical field as required for the scope of product review and planning, with a minimum of 4 years work experience in a relevant industry with technical support, quality control, quality assurance, process development, or manufacturing responsibilities. Or, appropriate life science or chemistry B.S. degree with 10 years work experience as detailed above.

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, and Quality Assurance activities.

5. Able to develop concise, clear written communication and presentations that contain both analysis and possible solutions.

PREFERRED QUALIFICATIONS:

1. In-depth technical knowledge in genomics, protein analysis, or cellular analysis evidenced by peer-reviewed publications.

2. Work experience in Quality Assurance from a regulated industry.

PHYSICAL REQUIREMENTS:

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.

 

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