Job Listings

Below you will find a list of our current opportunities.  You may click on the job title for more information and to apply, or you can search on specific criteria to find an opportunity that matches your interests.

 

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OUR TEAM: We are a motivated and caring team of individuals that support one another in providing quality assurance to existing products and new product development. We do this by partnering with our colleagues throughout the Promega organization, including Manufacturing, Quality Control, Research and Development, Marketing, Quality Systems, Technical Services, and others. YOUR ROLE: As part of our Product Quality Assurance team, you will be an important part of our product support and new product development teams, ensuring that all quality requirements are met. You will be expected to apply both your quality and scientific knowledge to support our Amplification products, which include purified enzymes and nucleotides. YOUR EXPERIENCE: We are looking for someone with a graduate degree in appropriate life science or chemistry field with a minimum of 4 years work, or someone with an appropriate life science or chemistry B.S. degree with 10 years of work experience. Experience should include a relevant industry with technical support, quality control, quality assurance, process development, or manufacturing responsibilities. This experience should also include a working knowledge and direct application experience of the requirements of quality assurance systems in a manufacturing and/or product development or process development environment. JOB OBJECTIVE: Provide product quality assurance by applying your technical and quality system knowledge to assure product quality and compliance to procedures throughout the product life cycle. 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 Manufacturing and Quality Control Protocols. 3. Review and approval of product labeling, including labels, technical literature and certificates. 4. Initiation, completion and signing of certificates as required for custom products and some catalog products. 5. Establish and approve shelf-life assignments for products in cooperation with Manufacturing, Marketing and R&D staff. This includes approval of study design, data review, and change management. 6. Assessing the scope and inventory impact of nonconforming product; approving Quarantine, Review and Disposition plans for inventory; assisting in the disposition planning for nonconforming product in branch inventories. 7. Participate in product or process improvement projects within product quality or quality system processes. 8. Assist in the preparation, review and/or approval of Design Control/New Product Realization documents. 9. Participate in the development of QC specifications and protocols that meet product and Quality System requirements. 10. Initiation, implementation, review and approval of product and process changes. 11. Reviewing, implementing, and participating in Corrective and Preventive Action plans. 12. Reviewing, implementing, and participating in product and process validation planning. 13. Reviewing, implementing, and participating in complaint investigation planning. 14. Write or revise Quality System documents as assigned. 15. Participate in team meetings to resolve planning and technical issues. 18. Understands and complies with ethical, legal and regulatory requirements applicable to our business. OCCASIONAL DUTIES: 1. Execute tasks/projects or special assignments as required. MANDATORY QUALIFICATIONS: 1. Minimum of a Bachelor’s degree in a biological or chemical science with 5+ years related experience in quality control, quality assurance, product support, or manufacturing. Note that advanced degrees may be considered towards years of experience. 2. Working knowledge of quality management systems, such as ISO9001, ISO13485, or 21 CFR 820. 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. Ability to perform analysis of complex problems or data requiring in-depth evaluation of various factors 6. A demonstrable track record of process improvement and effective procedure writing and revision. 7. Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results. 8. Able to develop concise, clear and accurate written communication. 9. Proven ability to work constructively with a broad range of people, backgrounds, and functions PREFERRED QUALIFICATIONS: 1. Work experience in a regulated industry (e.g. ISO 13485 or 21 CFR 820 compliance), specifically in the design and/or support of in vitro diagnostic medical devices. 2. Technical knowledge or experience in scientific areas specifically applicable to Promega products as described above. 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.   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.
Job ID
2021-2914
Category
Quality Assurance & Regulatory Affairs
OUR TEAM: We are a motivated and caring team of individuals that support one another in providing quality assurance to existing products and new product development. We do this by partnering with our colleagues throughout the Promega organization, including Manufacturing, Quality Control, Research and Development, Marketing, Quality Systems, Technical Services, and others.   YOUR ROLE: As part of our Product Quality Assurance team, you will be an important part of our product support and new product development teams, ensuring that all quality requirements are met. You will be expected to apply both your quality and scientific knowledge to support our DNA and RNA purification products, including working with and supporting external customers.  YOUR EXPERIENCE:  We are looking for someone with a graduate degree in appropriate life science or chemistry field with a minimum of 4 years work, or someone with an appropriate life science or chemistry B.S. degree with 10 years of work experience. Experience should include a relevant industry with technical support, quality control, quality assurance, process development, or manufacturing responsibilities. This experience should also include a working knowledge and direct application experience of the requirements of quality assurance systems in a manufacturing and/or product development or process development environment. 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*: *Note that the emphasis placed on the essential duties listed here will vary by individual, depending on the focus and balance of that person’s specific responsibilities. 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.     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.
Job ID
2021-2849
Category
Quality Assurance & Regulatory Affairs
OUR TEAM: We are a motivated and caring team of individuals that support one another in providing quality assurance to existing products and new product development. We do this by partnering with our colleagues throughout the Promega organization, including Manufacturing, Quality Control, Research and Development, Marketing, Quality Systems, Regulatory Affairs, Technical Services, and others. YOUR ROLE: As part of our Product Quality Assurance team, you will be an important part of our product support and new product development teams, ensuring that all quality requirements are met. You will be expected to apply your quality knowledge to support our In Vitro Diagnostic and Medical Device technologies. YOUR EXPERIENCE: We are looking for someone with Quality experience related to In Vitro Diagnostics and/or Medical Devices. This experience should include a working knowledge and direct application experience of the requirements of quality assurance systems in a manufacturing and/or product development or process development environment. Scientific background is preferred, and knowledge of DNA technologies is also preferred, but not required. JOB OBJECTIVE: Provide product quality assurance to ensure that Promega In Vitro Diagnostics and Medical Devices products comply with regulatory and quality system requirements. Provide both quality and scientific input to cross-functional teams in support of existing products and new product development.   1. Promega catalog and custom products meet their predetermined performance, process, and system requirements for quality. 2. Product and Process Changes and Quarantine disposition plans are implemented according to established procedures. 3. Technical literature (PPIs, labels, Technical Bulletins etc) are accurate and consistent. 4. Product performance claims and release criteria are based on objective data analysis. ESSENTIAL DUTIES: Note that the emphasis placed on the essential duties listed here will vary by individual, depending on the focus and balance of that person’s specific responsibilities. 1. Audit, data review, and approve product batch records for the next manufacturing step or availability in inventory. 2. Review and approve Manufacturing and Quality Control Protocols for catalog and custom products. 3. Review and approve product labels. 4. Establish and approve shelf-life assignments for catalog and custom products in cooperation with Manufacturing, Marketing, Regulatory Affairs and R&D staff. This includes approval of study design, data review, and 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 approve Promega Product Information (PPI) specification sheets and Certificates of Analysis; initiation, completion and issuance of these documents as required for custom products and some catalog products. 7. Assess the scope and inventory impact of nonconforming product situations; approving disposition plans of inventory product under quarantine; assisting in the disposition planning for nonconforming product in branch inventories. 8. Assist in the preparation, review and approval of design control documents. 9. Initiate, implement, review and/or approve Product and Process Change Plans. 10. Review, implement, and/or participate in Corrective and Preventive Action plans. 11. Review, implement, and participate in product and process validation planning. 12. Review, implement, and participate in complaint investigation planning. 13. Participate in process mapping and SOP development as directed. 14. Write SOPs as assigned. 15. Participate in team meetings to resolve planning and technical issues. Propose constructive solutions to existing problems. 16. Evaluate risks based on customer, technical, business and regulatory factors, provide options and recommendations to mitigate risk. 17. Consider basic regulatory requirements in product or process issues. 18. Understand and comply 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. Organize and implement training programs in areas of expertise and experience. 5. Participate in continuous improvement projects. MANDATORY QUALIFICATIONS: 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. PREFERRED QUALIFICATIONS: 1. Technical knowledge in DNA-related technologies. 2. Work experience in Quality Assurance from a regulated industry involving medical devices. 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.   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.
Job ID
2021-2788
Category
Quality Assurance & Regulatory Affairs