Production Compounder/Formulator, 3rd shift

About the role

This role works in our manufacturing facility in New Hope, MN. The position requires proficiency in formulating oral solid dosage (OSD) or life science solutions (LSS) products. Responsibilities include following procedures, setting up, processing, and cleaning equipment, executing complex batch records, and ensuring adherence to Good Manufacturing Practices (GMP).

Responsibilities

• Prepares batches of raw materials for production processing according to specifications and established procedures.
• Ensures efficiency and effectiveness (RFT) for both manufacturing and documentation.
• Ensures no known defects are passed to upstream processes.
• Responsible for efficient and effective set-ups, cleaning, and changeovers.
• Obtains materials from inventory and utilizes scales or automated equipment to accurately weigh.
• Cleans and sanitizes processing equipment, tanks, filters, pipes, lines, and pumps.
• Follows hazardous material handling and personal protective equipment (PPE) requirements, if applicable.
• Trains/coaches others and personally adheres to Standard Operating Procedures (SOPs), cGMPs, DEA, and Safety guidelines.
• Identifies and communicates compliance, safety, and/or quality issues to the next level.
• Completes all documentation or logbooks accurately and in accordance with GMP.
• Ensures 5S in applied in area of responsibility and as part of daily work.
• Participates in and trains others in monthly Quality and PASS audits.
• Participates and/or leads investigations and continuous improvement initiatives as it relates to quality, safety, productivity, and cost.
• Ensures personal training is up-to-date in Learning Management System.

Requirements

• High School Diploma/GED required.
• Strong math aptitude (calculations, percentages).
• Previous production knowledge and experience.
• Demonstrated ability to execute right-the-first-time Batch Records, Log Books, and other documentation in compliance within good documentation practices.
• Excellent attendance and work history.
• Computer proficiency.

Additional requirements

• Physical requirements: must be able to stand on concrete floors for extended periods of time, lift up to 50 lbs frequently, ascend and descend stepladders, push or pull up to 1200 pounds, stoop, squat, and bend, reach laterally regularly and overhead, occasionally frequently grasp objects, wear negative and/or positive PPE (e.g., dust mask, PAPR) daily for long periods of time, must possess sufficient visual and audio acuity to work safely and accurately in an industrial environment, must be medically cleared to wear respirators without restrictions.

Key competencies

• Service delivery – Understand who your internal and external customers are, identify their needs, and deliver value above their expectations.
• Active collaboration – Seek opportunities to work together across teams, function, business units, and geographies to seek success.
• Demonstrate agility – Proactively identify changes in our environment and act quickly, leading or embracing change.
• Think differently – Create, develop, and implement new ideas, products, services, or processes that involve introducing something new or significantly improving something that already exists.
• Excellent execution – Achieve outstanding results in all aspects of our organization, including our culture, leadership, strategy, and processes.

About us

At Padagis, our focus is on health care products that improve people's lives. We are a market-leading generic prescription pharmaceutical company specializing in "extended topical" medications, such as creams, foams, mousses, gels, liquids, and inhalable products. It's a great time to join our team as we have a high growth trajectory with more than 1,300 employees across six locations in the United States and Israel. We've established a successful track record of launching first-to-file and first-to-market generic pharmaceutical products that have made prescription products more affordable for patients and reduced costs for the healthcare system. Our team members work in a dynamic environment where opportunity is built on a foundation of honesty and transparency.