Responsible for activities involving quality assurance and compliance with company quality policies and procedures in a chemical manufacturing environment. Works across a variety of quality assurance disciplines. This position audits and reviews quality data according to existing documents and procedures, ensures employees follow established procedures, and evaluates and makes recommendations on improvement opportunities related to quality-related processes and product quality.
1. Requires a bachelor's degree; science-related field preferred.
2. Requires 4 to 7 years of experience in quality assurance or related field.
3. Knowledgeable of quality standards and regulations, with industry experience in ISO 9001 required; industry experience in ISO 13485 and/or cGMP/QSR FDA regulations is a plus.
1. Stay current on ISO 9001 standard and maintain thorough knowledge of company quality policies and procedures.
2. Monitor conformance to established quality assurance processes and standards. Utilize metrics and other quality data to determine conformance and drive improvement. Identify risk and evaluate deficiencies while working with internal departments/business units to appropriately remedy them.
3. Provide leadership in quality planning, process improvement, and change management within the organization.
4. Responsible for the Non-Conformance, Deviation and CAPA process. Participate in Material Review Board investigations to resolve potential product quality issues and document findings.
5. Responsible for internal audit program. Includes overseeing the internal audit process, annual schedule, auditor qualification, and documentation.
6. Review/approval of new part numbers, for adherence to quality policies. Assist the QA Manager with other new product development tasks, as assigned.
7. Review/approval of Quality Control Inspection Plans and C of A templates.
8. Under direction of the QA Manager, review/approval of changes to the manufacturing processes, test methods and specifications. Monitoring of adherence to applicable Quality Agreements.
9. Write and revise quality-related procedures as needed.
10. Under the direction of the QA Manager, will perform suitable preparation, data collection and analysis, and creation of reports and presentations to support various QA Department activities, including (but not limited to) Management Review meetings, ISO registrar audits and external customer audits.
11. Facilitates internal training on quality assurance requirements, processes, and procedures.
12. Lead continuous improvement projects as assigned by QA Manage.
13. Understand and comply with ethical, legal and regulatory requirements applicable to our business.
Must be able to move about the facility, conducting audits, etc. Requires frequent stair climbing, as office is located on upper floor. Requires working with computers and telephone for long periods of time. Must be able to use a variety of other office equipment. Requires corrected vision for near (within 20cm) and far (greater than 3m) sight. May require some occasional moderate lifting. Safety glasses must be worn in all but the administrative areas.
Promega Biosciences, located in San Luis Obispo, blends innovative research in chemistry with excellence in manufacturing to meet the rapidly changing needs of the scientific community. We synthesize and manufacture essential reagents to help Promega succeed as a life science leader.
Our areas of expertise include synthesis, process design and scale-up, and commercial manufacturing (grams to kilograms) of modified luciferins and coelenterazines. These pro-bioluminescent products aid in life science research. We bring pride, passion, and purpose to our work and the products we provide.
Promega Biosciences offers its employees a work environment that encourages creativity, work-life balance, and personal and professional growth. We support community involvement and are committed to being good stewards and reducing our impact on the environment. Promega fosters a positive, fun, and warm family culture. To learn more about our values, please visit our Corporate Responsibility website.
We offer a competitive salary and benefits package including comprehensive medical insurance, dental and vision insurance, 401k matching, company-paid life insurance, time-off benefits, and more.
Our San Luis Obispo facility is at the heart of California’s beautiful central coast. San Luis Obispo is a destination for wine aficionados, nature lovers, and pleasure-seekers alike. You might enjoy views of the Pacific Ocean from one of our scenic Nine Sisters, a chain of volcanic peaks that run along the coast. Or, spend a day gallivanting around the many wineries, local boutiques, and renowned restaurants in the area. Proclaimed as the “happiest town in the USA”, our community provides a rich and rewarding place to live and play. To learn more about San Luis Obispo, check out the VisitSLO website.
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.