OUR TEAM: Our Quality Control team plays a vital role in supporting Promega’s Manufacturing and New Product Development teams at the San Luis Obispo, CA facility. Using a variety of advanced analytical techniques, we ensure the quality and reliability of our diverse product portfolio. We value integrity, clear communication, and a collaborative spirit in our team members. By fostering a culture of continuous improvement and innovation, we strive to enhance our processes and create a dynamic, supportive, and engaging workplace where every team member can thrive. YOUR ROLE: As a Quality Control (QC) Associate 3 at Promega, you will play a pivotal role in ensuring the quality of our manufactured products. In this role, you will perform accurate and reliable product testing using established protocols, analyze and report findings clearly, and contribute to maintaining compliance with Promega’s Quality System. You will also mentor less experienced associates, fostering a culture of growth and collaboration. Proficiency in the ERP quality module is essential, as you will use this system to manage quality-related tasks effectively. Additionally, you will participate in daily morning meetings to prioritize testing and tasks, ensuring alignment with team objectives and company goals. Open and effective communication with team members will be vital in supporting collaborative problem-solving and achieving quality standards. Join Promega and contribute to our mission of delivering high-quality products that make a difference in the world. The expected starting salary range is $83,000 - $87,000/year, depending on experience. The full salary range for this position is $80,155 - $120,232. JOB OBJECTIVE: Conducts routine and non-routine analyses of samples submitted to the QC Lab, including but not limited to chemical and biochemical analysis of raw materials, in-process, finished product and stability testing according to established operating procedures. Reviews and interprets data for adherence to specifications and reports anomalies; collaborates with Manufacturing and other Chemistry staff to troubleshoot issues. Thorough understanding of operation and maintenance of analytical instruments and associated software and data processing. Works independently on QC Lab projects and tasks according to established priority. CORE DUTIES: 1. Analyzes routine and non-routine raw material, intermediate and finished good samples submitted to QC, following written test methods and inspection plans, according to inventory deadlines. 2. Analyzes routine and non-routine in-process samples and works collaboratively with Manufacturing to interpret results and troubleshoot. Recommends any potential improvement of in-process methodology to better meet Manufacturing requirements. 3. Evaluates and interprets results from analytical instruments used in the QC lab for sample testing, performing calculations as required. Reviews sample data obtained for adherence to specifications or targets, and reports abnormalities, inconsistencies, or non-conformance to Supervisor. Demonstrates good judgement to determine appropriate action. 4. Enters data evaluated for compliance to specification into Quality database, with accompanying documentation of test data, according to QC lab policies and procedures. 5. Supports QC Lab investigations and activities related to product or process non-conformance investigations. Troubleshoots method, instrument, and QC processes to find root cause and makes proposal for corrective action as applicable. Reports results to the Supervisor and completes documentation of investigation as directed, according to QC Lab policies and procedures. 6. Coordinate QC Lab stability studies, adhering to scheduled test points, data collection and interpretation, and report writing per QC policy. Analyzes routine and non-routine stability samples as needed. Makes shelf-life recommendations as applicable. Reports abnormalities or inconsistencies observed. 7. Thorough understanding of instrument theory, methods, and operation for commonly used QC Lab instrumentation, such as HPLC, LC/MS, NMR, Spectrophotometer, Luminometer, Fluorometer and Karl Fischer. Function as analytical instrumentation subject matter expert for QC and provide training and technical support to QC staff. Collaborate with LSS or IT groups on resolution of instrument issues. 8. Learns and effectively uses instrument software, Microsoft Office applications, ERP system such as SAP, and any other software applications needed to support data processing and QC documentation. Function as subject matter expert on software, providing training and technical support to QC staff. 9. Supports New Product Realization projects as assigned. Analyzes samples to support process design and collaborates with project team members. Prepares Inspection Plan, COA Profile, Stability Report and other related documentation for approval as directed by Supervisor. Attends cNPR team meeting upon request. 10. Performs test method optimization and re-validation, and test method transfer activities, as directed by Supervisor. Provide evaluation of resources required and ROI if requested. 11. Participates in planning process for required QC testing, based on Manufacturing schedule. Ensures reagents and standards are available to meet planned test schedule. Performs any tasks or testing required for seamless QC lab operation. 12. Creates new documentation and recommends revisions to QC test methods, standard operating procedures and forms, inspection plans, COA profiles, QC notebooks and product master data to address gaps, improve clarity and reflect actual practice. Identifies any risk to products or processes associated with revision. 13. Prepares written reports and presents scientific results and conclusions, and other QC-related data, clearly and concisely to large and small groups within the company as directed by Supervisor. 14. Mentor’s junior analysts in the QC group on methods and processes. Provides training as needed. May supervise project employees on occasion. 15. May be assigned by Supervisor as lead QC analyst on a process improvement or other project team; method optimization or new method development may be required as part of project scope. 16. Function as back-up to Supervisor, or other QC analysts, on occasion. 17. May travel on occasion. 18. Understands and complies with all applicable elements of PBI's quality management system. May serve as an internal auditor on occasion. 19. Understands and complies with all applicable elements of PBI’s EHS processes. Participates in weekly lab safety checks. May serve on the Safety Committee on occasion. 20. Demonstrates inclusion through their own words and actions and is accountable for a safe workspace. Acts with kindness, curiosity, and respect for others. 21. Embracing and being open to incorporating Promega’s 6 Emotional & Social Intelligence (ESI) core principles in daily work. 22. Understands and complies with ethical, legal and regulatory requirements applicable to our business. KEY QUALIFICATIONS: 1. BS or MS in Chemistry, Biochemistry, or other related lab science, plus 4-7 years’ experience in an analytical lab, using advanced analytical instruments and techniques. Demonstrated ability to successfully troubleshoot analytical assays, instruments and product issues. 2. Experience operating and maintaining analytical instruments for QC testing of small molecules. Examples of instrumentation such as HPLC, Mass Spec, NMR, Spectrophotometer, Karl Fischer, and associated software and data processing tools. Demonstrated ability to learn new instrumentation and software. 3. Knowledge of basic statistics such as mean, standard deviation, confidence intervals, and linear regression. Experience with use of statistical tools to analyze data. 4. Experience with ISO9001, or other quality system requirements applicable to a Quality Control Lab. 5. Must possess a very high level of attention to detail and utilize scientific thought and critical thinking in a Quality Control Laboratory setting. Must possess problem-solving skills. 6. Proven ability to work collaboratively in a team environment. PREFERRED QUALIFICATIONS: 1. Experience with method validation. 2. Ability to break down large complex issues into smaller pieces and understand the critical underlying issues. Demonstrated ability to make decisions with routinely good results. 3. Ability to prepare written reports and present scientific results and conclusions to a large group. 4. Ability to train and mentor junior analysts and provide leadership in the QC Lab. 5. Experience with ERP systems such as SAP. PHYSICAL DEMANDS: 1. Must be able to move about the facility and labs while performing the tasks described above. 2. Must be able to remain stationary for several hours at a time. 3. Must be able to effectively operate all aspects of analytical instrumentation and prepare samples using associated lab equipment such as pipettes and balances. 4. Must be able to identify and distinguish colors. 5. Must be able to work with chemical reagents required for analytical testing. 6. Must be able to wear appropriate personal protective equipment such as lab coat, mask, gloves, hair covering and safety glasses and work in a laminar flow hood. 7. Must be able to move and transport objects averaging 10 pounds. 8. Must be able to position oneself in a low position. 9. Must be able to position oneself in a high position to access instrumentation and reagent bottles. 10. Must be able to use a computer for several hours at a time throughout the day. At Promega, we value diversity and strive to create an inclusive workplace. We are proud to be an Equal Opportunity Employer, making employment decisions without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, disability, or any other protected class.