We are hiring Formulators at our manufacturing facility in New Hope, MN. They will be proficient and able to perform most formulation functions within OSD or 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. Understands, trains others in, models the ideal behavior and follows all regulations including FDA, DEA, MNOSHA, etc. Team oriented, good collaborator and able to manage workload efficiently including using downtime to improve systems and processes. 

Schedule: Monday through Friday (2nd Shift)

Minimum time in position (prior to progressing to next level): 2 years

Technical competencies, skills and certifications:

• High School Diploma/GED required
• Strong math aptitude (calculations, percentages)
• Previous production knowledge and experience required
• Executes Right-the-first-time Batch Records, Log Books and other documentation in compliance with good documentation practices
• Must possess an excellent attendance and work record.
• Computer navigational skills

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. Pariticpates 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 Aspect of Work:

• 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 Information: 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.