We are hiring Formulators at our manufacturing facility in New Hope, MN. These roles require proficiency in performing most formulation functions within Oral Solid Dosage (OSD) or Life Science Solutions (LSS). Responsible for the following all procedures, batch records and other written instructions and executing right-the-first-time formulation of product including the set-up, processing, and cleaning of equipment. Executes complex Batch Records/GMP processes which may include handling of controlled substances and potent drugs. First, second, and third shifts may be available (please indicate your preference when completing the online application).

Successful candidates will understand, trains others in, and models ideal behavior and follow all regulations including FDA, DEA, MNOSHA, etc. Team oriented, good collaboration skills, and demonstrated ability to manage workload efficiently (including using downtime to improve systems and processes) required.

Requirements:

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

Responsibilities:

• Responsible for formulation operations ensuring efficiency and effectiveness (RFT) for both manufacturing and documentation. Ensures that no known defect is passed to upstream processes.
• Responsible for efficient and effective set ups, cleaning and changeovers.
• Trains/coaches others and personally adheres to SOP, cGMP, DEA and Safety compliance. Identifies and communicates compliance, safety and/or quality issues to next level.
• Ensures 5S in applied in area of responsibility and as part of daily work. Particpates 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, on time deliver or other related duties specific to the department as assigned.
• Ensures personal training is up-to-date in Learning Management System

Physical requirements:

• Must be able to stand on concrete floors for extended periods of time. Must be able to lift up to 50 lbs frequently. Must be able to ascend and descend stepladders. Must be able to push or pull up to 1200 pounds. Must be able to stoop, squat, and bend. Must be able to frequently reach laterally, and overhead occasionally. Must be able to frequently grasp objects. Must possess sufficient visual and audio acuity to work safely and accurately in an industrial environment. Must be able to work a minimum of 40 hours per week.

• Have to be able to wear negative and/or positive PPE (e.g., dust mask, PAPR) daily for long periods of time. 

• Must be medically cleared to wear respirators without restrictions. 

Additional requirements:

• Required to follow and comply with Standard Operating Procedures (SOPs), Good Manufacturing Practices (GMPs), and Safety/Housekeeping guidelines.
• Possesses knowledge and skills to lead continuous improvement initiatives as well as quality investigations, which may require basic computer skills.