Quality Control Analytical Scientist 3

OUR TEAM: We are a focused team of analytical Quality Control professionals who are responsible for in-process and final API testing. We are passionate about our work and enjoy the diverse challenges that come from our role working across multiple teams to all achieve a successful outcome. We work hard to support each other and celebrate individual and team success!

YOUR ROLE: As QC Analytical Scientist 3 you will work primarily in the laboratory performing a wide diversity of tests required for API release and stability assessment. You will also be involved in new method development and Validation. You will also support the training of fellow team members on instrumentation and test methods. Your impact will be as a key team member with unique skills and chemistry knowledge that benefit the QC team and broader manufacturing operations teams.

JOB OBJECTIVE: Independently perform complex analytical testing, method validation, and laboratory investigations. Mentor junior scientists and contribute to continuous improvement of QC analytical methods, instrumentation, and compliance practices.

CORE DUTIES:

1. Perform analytical method validation and characterization independently to support process improvement, product transfer, or new product realization projects.

2. Lead investigations of Out of Specification (OOS) results and nonconformances, identifying root causes and corrective actions.

3. Draft, review, and revise QC procedures, including SOPs, protocols, and inspection plans, ensuring compliance with documentation policy.

4. Act as lead analyst for complex QC testing of raw materials, intermediates, and final products.

5. Mentor and train QC Analytical Scientist 1 and 2 staff in laboratory methods, instrumentation, and good documentation practices.

6. Maintain and troubleshoot QC Lab instrumentation and associated analytical methods utilized for product release testing. Perform analytical method evaluation and/or re-validation upon request, as part of Installation / Operation / Performance Qualification efforts related to new or changed laboratory instrumentation.

7. Evaluate and interpret complex analytical testing results and ensure accurate reporting.

8. Report results of release testing according to company Quality System requirements. This includes the input of results into SAP Quality Module and issuing COA's as needed.

9. Contribute to retention, reference standard, and stability program management.

10. Champions the use of AI and digital tools to enhance team efficiency and operational quality.

11. May require occasional work outside of standard business hours, including evenings and weekends, to meet organizational needs.

12. Demonstrates inclusion through their own words and actions and is accountable for a safe workspace. Acts with kindness, curiosity and respect for others.

13. Embracing and being open to incorporating Promega's 6 Emotional & Social Intelligence (ESI) core principles in daily work.

14. Understands and complies with ethical, legal and regulatory requirements applicable to our business.

KEY QUALIFICATIONS:

1. BS in Chemistry or related field with 3+ years QC experience, or MS with 2+ years QC experience.

2. Demonstrated record of independent method validation and characterization.

3. Strong knowledge of analytical instrumentation (HPLC, LC-MS, GC, NMR, ICP-MS, Karl Fisher, XR-PD, FTIR, spectrophotometers, etc.).

4. Proficiency with statistical analysis tools (mean, SD, regression, confidence intervals).

5. Experience in mentoring or training staff.

6. Demonstrated proficiency in digital tools and technology, including Microsoft applications and mobile platforms, with the ability to adapt and leverage emerging technologies, such as artificial intelligence, to improve efficiency, automation, and collaboration.

PREFERRED QUALIFICATIONS:

1. MS with 3+ years QC laboratory experience preferred.

2. Familiarity with regulated environments such as ISO 9001, cGMP, 21 CFR 211, or ICH Q7.

3. Proven ability to manage multiple projects and priorities.

4. Strong organizational, problem-solving, and communication skills.

PHYSICAL DEMANDS:

1. Must be able to move about the building and labs while performing the tasks described above.

2. Must be able to stand for long periods.

3. Must be able to identify and distinguish colors.

4. Ability to work with chemical reagents required for analytical testing.

5. Ability to use a computer and multiple software applications.

6. Must be able to wear appropriate personal protective equipment such as lab coat, mask, gloves, and safety glasses.

7. Ability to move objects up to 20 pounds.

8. Must be able to use a computer for extended periods of time throughout the day.

9. Ability to travel.

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.