Established in 1978, Threshold Enterprises is an industry leader in the manufacture and distribution of award-winning Source Naturals® and Planetary Herbals™ nutritional supplements. Our vision is to be the solutions provider for our consumers’ desire to enjoy optimal health and well-being by providing fine quality dietary supplements and nutritional education. Headquartered in Scotts Valley, CA we also have locations in Santa Cruz, Watsonville, and Winchester, Virginia, employing over 600 team members.
Summary of Job Duties: Provide and document timely, real-time support to Manufacturing operations, with limited direction and supervision. Use tablet and capsule product and process knowledge to provide technical support, implement improvements, and achieve permanent solutions, towards more batches “right-the-first-time.”
Specific Job Duties:
- Work with limited supervision in a fast-paced nutritional supplement manufacturing environment with close attention to products, processes, and equipment.
- Perform tasks safely, with a focus on current Good Manufacturing Practices (cGMP) and current Good Documentation Practices (cGDP), in a fast-paced manufacturing environment.
- Support Manufacturing by responding to help requests, investigating, diagnosing, and troubleshooting product issues and recommending solutions.
- Tableting issues: sticking, capping, chipping, compressibility, disintegration.
- Encapsulation issues: sticking, dents, headroom, capsule shell defects
- General issues: machine setup, machine performance, product testing, documentation.
- Perform physical tests on samples, record and interpret results.
- Execute the recommended solutions, complete appropriate documentation, and communicate changes.
- Perform calculations for additional excipients to improve product performance.
- Complete documentation related to changes: ingredient change forms, in-process deviations, batch record corrections, processing forms.
- Work with area leadership, associates, and leads to create great service for internal manufacturing customers.
- Interact with multiple departments, including Quality Control, Quality Assurance, Production Control, and Manufacturing to ensure timely support of manufacturing processes and products.
- Perform various functions in the Manufacturing Department, including, but not limited to Granulation, Blending, Compression, Encapsulation, and Coating.
- Develop technical expertise in one or more unit operations (for example, wet granulation and compression).
- Perform troubleshooting and root cause analysis to support permanent changes for manufacturing issues and concerns.
- Review of production batch records and master manufacturing records.
- Provide leadership and help coordinate efforts of other team members.
- Any tasks assigned by Threshold Management
Minimum Qualifications Required:
- Five years of experience in a cGMP environment.
- Three years of experience in solid oral dose manufacturing.
- Must be able communicate in English both written and verbal.
- Must be able to lift 40 + Lbs.
- Must be able to stand and sit for long periods; squat, twist, kneel and bend occasionally.
- Must be able to pass a company test with a minimum of 50%.
- Skilled in basic computer use and software (i.e. Windows, MS Word, MS Excel, Navision).
- Familiar with basic units of measure and unit conversion.
- Familiar with basic algebra to perform calculations.
- High School Diploma or equivalent (especially with courses in math, chemistry, physics).
- Ability to learn through instruction and training.
- Ability to be observant and have high attention to detail, even when performing repetitive tasks.
- Desire for career and personal development and improvement.
Skills and/or Training Preferred But Not Required:
- Bilingual (Spanish and English).
- Tablet press setup and operation.
- Solid oral dose development or manufacturing experience with understanding of critical product attributes and critical processing parameters for various manufacturing unit operations.
- College coursework or degree in science-related discipline.
- Familiar with common excipients in nutritional supplements, their functions and basic properties.
- Familiarity with FDA guidance and regulations.
- Familiar with common in-process testing techniques.
- Tablet weight, thickness, hardness.
- Tablet Friability.
- Granulation density (bulk and tapped).
- Particle Size testing.
- Loss on Drying.
- Experience with problem solving techniques and root cause analysis.
Mechanical skills (understanding machines, working with tools)
To APPLY, visit our website, or come see us at 19 Janis Way, Scotts Valley.