Sr. Quality Assurance Scientist 1 - Product Quality Promega
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JOB OBJECTIVE: Assure product quality and compliance to procedures throughout the product life cycle, using a quality system and risk based approach that is appropriate for the intended use of the product. Lead improvements and corrective actions and support the organization as a QA representative, working directly with customers and on cross-functional teams within the organization.
1. Assures conformance to established quality assurance processes and standards for development, manufacturing and Quality Control (QC) testing of products through review of
o Work instructions
o Customer and product requirements, including QC specifications
o Batch records
o Product labeling, including instructions for use, certificates of analysis, and labels
o Nonconformance documentation
o Product stability documentation
o Change control packets
o Complaint investigations
o Method and process validation documentation, as required
2. Serve as primary independent Quality Assurance (QA) resource on new and custom product development teams.
o Review and approval of new product development documents
o Product and customer requirements
o Design verification and validation protocols and reports
o Risk analysis
o Intended use statements
o Participation in design transfer of new products into production
o Review and approval of custom product development documents
3. Support products throughout all phases of product lifecycle from development through on-market support.
4. Ensures product documentation complies with internal procedures, external quality standards, and customer requirements.
5. Facilitate product or process improvement projects within product quality or quality system processes. Mentor other employees on quality assurance requirements, processes, and procedures.
6. Work directly with customers to resolve complaints, support customer audits, and develop and improve customer relationships.
7. Understand and comply with ethical, legal and regulatory requirements applicable to our business.
1. University degree (B.S., M.S., or Ph.D.) in a biological or chemical science and a minimum of 6-10 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, including ISO9001, ISO13485, or 21 CFR 820.
3. Ability to apply basic statistical concepts to analytical data.
4. Ability to communicate (in written and oral forms) in a concise, clear, and accurate manner.
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. 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.
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 Equal Opportunity/Affirmative Action Employer
Madison, Wisconsin, United States
||2800 Woods Hollow Road |
Madison, WI 53711
THIS JOB HAS EXPIRED