Analytical Chemist II

At Apex International, we take pride in our commitment to manufacturing high-quality over-the-counter, personal care, and household products. We strive to build collaborative partnerships with a diverse range of customers, including global Fortune 100 companies and entrepreneurial start-ups. In our ongoing effort to provide the best experience for our customers, we continually seek new candidates.

We are currently seeking an Analytical Chemist II who will contribute to the growth and success of our customers by ensuring raw materials, bulk, and finished products manufactured meet customer and regulatory analytical requirements. This salaried role reports to the Quality Control Manager and will be a key member of our quality team at our Eden Prairie and Chaska production locations.

Job Responsibilities and Job Duties

1. Validates procedures/processes, test methods/chemical assays, and equipment that the lab employs to detect and identify active ingredients to ensure compliance with customer and regulatory guidelines

• Validates analytical test methods to ensure compliant methods are used for testing controlled articles (raw materials, bulk, filled product).
• Calibrate, monitor, and maintain test equipment on a daily, weekly, and annual basis to ensure optimal performance.
• Assist with Cleaning Validations (active ingredient residues) on equipment to ensure the effectiveness of the cleaning process.

1. Utilizes data to focus improvement efforts, ensuring that customer and regulatory requirements are met.

• Accurately records all data (cGMP) and pertinent information.
• Accurately creates monthly Key Quality Indicators (KQI) promptly.
• Conducts batch record review to determine compliance with cGMP practices
• Documents OOS situations and determines the root cause and possible CAPA.
• Leads OOS investigations and reviews, and approves ADPRs (fill and stability).

1. Ensures analytical specifications are met and that results are documented and maintained to the customer's satisfaction.

• Reports test results and ensures accurate and timely transition of quarantined raw materials, bulk product, and finished products based on those results.
• Releases product that meets initial specifications and documentation requirements.
• Troubleshoot out-of-specification (OOS) situations.
• Ensures Good Laboratory Practices (GLP) that comply with regulatory guidelines.
• Ensures laboratory notebooks are maintained and up to date.
• Participates in internal and external audits.

1. Foster and maintain a culture of "lean action" within the department, enabling us to operate leaner than any other origanization.

• Implement and maintain standards and processes that eliminate waste throughout the department.
• Apply and utilize "lean tools" to permanently implement improvements
• Institutionalize 5-S in all aspects of the department. (Sort, Straighten, Shine, Standardize, and Sustain)

1. Perform other work as assigned.

Qualification and Skill Requirements

• Must have 6+ years of experience in a cGMP Laboratory. Preferred experience includes that in a manufacturing environment.
• Must have prior experience with USP and HPLC.
• Lab experience usually acquired through a 4-year college degree in Chemistry, Biology, or a related science discipline, and/or equivalent experience is needed.
• Prior experience with method validation and method development is strongly preferred.
• Prior experience in training and mentoring others.
• The ability to multitask, demonstrate a sense of urgency, and organize.
• Demonstrated understanding of relevant CFR (21 CFR, Part 210 and 211) and can ensure laboratory compliance with current regulatory requirements. Is a subject matter expert in appropriate areas with some knowledge/experience in manufacturing process/development regulatory requirements.

Work location and onsite work requirement

• Apex International has two production locations in the Minneapolis metro area, one in Chaska and the other in Eden Prairie. This role requires full-time, onsite work primarily at our Eden Prairie location, with occasional onsite work at our Chaska facility when needed, typically no more than once per week.

Keywords or Similar Job Titles or Skills

• Method Development, Method Validation, Validation Chemist, Wet Lab, Titration, USP (United States Pharmacopeia), HPLC (High-Performance Liquid Chromatography), GC (Gas Chromatography), Quality Control, Analytical Scientist, Quality Control Analyst, Quality Control Scientist

Additional Information

Apex International's dynamic nature, unwavering commitment to quality, implementation of Lean Manufacturing practices, financial strength, and focus on customer satisfaction, combined with problem-solving employees, have propelled us to become a prominent industry leader in contract manufacturing for the personal and home care sector.

As a leader in contract manufacturing, Apex stands out due to:

• Unrivaled commitment to quality: Apex sets itself apart with its measurable advantage in delivering products of the highest quality standards.
• Emphasis on Lean Manufacturing and continuous improvement: Apex is dedicated to implementing Lean Manufacturing practices, constantly seeking ways to optimize processes and enhance efficiency.
• As a privately held company with strong financial stability, Apex ensures reliability and long-term partnership opportunities.
• Customer-focused and problem-solving employees: Apex boasts a team of highly skilled and dedicated employees who excel in customer service and possess exceptional problem-solving abilities. Our commitment to meeting customer needs is unparalleled.

Apex International Inc. is an equal opportunity Employer.