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.
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.
1. Execute tasks/projects or special assignments as required.
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
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.
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.