QC Technical Analyst 1 (On Site)

Posted 11 Days Ago
Be an Early Applicant
95066, Scotts Valley, CA, USA
In-Office
19-19 Hourly
Junior
Healthtech
The Role
Evaluates raw material and finished-product test results, specifications, supplier documentation, and Certificates of Analysis for acceptability and cGMP compliance. Processes, releases, or rejects materials; manages records in Microsoft Dynamics Navision; investigates expired materials; supports supplier qualification, audits, corrective actions, documentation review, waste sorting, team training, and continuous improvement. The role requires careful adherence to SOPs, safety procedures, and Good Documentation Practices in an on-site production environment.
Summary Generated by Built In

Summary of Job Duties:

The Quality Control Technical Analyst I is responsible for evaluating test results from in-house and contract laboratories, specifications, and information received from suppliers and contract manufacturers to determine acceptability of ingredients for use in nutritional supplement production. This position works closely with Purchasing, Quality Assurance and Research & Development to ensure cGMP compliance of ingredients, products, and processes.

 

Specific Job Duties:

  1. Process incoming raw materials including intake, sample submission, interpretation of test results, write up, dispositioning of materials as released or rejected, stickering, and scanning and filing of completed Certificate of Analysis (CoA) packets.
  2. Interpret laboratory test results and supplier/ contract manufacturer documentation and evaluate them against established internal specifications for ingredients and finished products.
  3. Review and request information from suppliers as required on internal specification sheets and submit spec update requests as needed.
  4. Use the Enterprise Resource Planning (ERP) software, Microsoft Dynamics Navision, to track physical location, status, and ownership of materials in process.
  5. Investigate and recertify expired raw materials (ERMs) to extend expiration dates.
  6. Review and approve supplier documents as part of the Supplier Qualification and Material Assessment processes.
  7. Peer review Certificate of Analysis (CoA) packets for accuracy and Good Documentation Practices (GDP).
  8. Sort leftover sample materials into appropriate hazardous and non-hazardous waste streams.
  9. Assist other team members in learning and completing tasks as needed.
  10. Assist team with routing documents for further review, tracking area supplies and items needed to order, tracking self-productivity metrics, and answering questions about own materials.
  11. Participate as a fully engaged member of a self-directed work team to set and achieve department and company goals. Participate in continuous improvement initiatives to improve department processes.
  12. Closely follow Safety and departmental SOPs.
  13. Provide support to internal audits and follow through with any corrective actions pertinent to the Quality Control Technical Analyst group.
  14. Perform all other tasks as assigned by Threshold management.
Qualifications

Minimum Qualifications Required:

 

  1. Associate’s or Bachelor’s degree or equivalent education and experience, preferably in a science-related field.
  2. Good written and verbal communication skills, with great attention to detail.
  3. Proficient in Microsoft Outlook, Word, and Excel.
  4. Good math skills and familiarity with general scientific terminology, particularly in chemistry and biology.
  5. Strong computer and technology literacy, and ability to learn various data tracking software programs.
  6. Willingness to maintain full self-accountability, accountability as a team, and to integrate constructive criticism.
  7. 20/20 or corrected vision.

 

 

Skills and/or Training Desired:

 

  1. 1 year of experience in Quality Control, Quality Assurance, and/or Research & Development.
  2. 1 year of experience in a GMP/GDP production environment.
  3. Experience with enterprise resource planning (ERP) software such as Microsoft Dynamics NAV.
  4. Proficient in Microsoft PowerPoint, Visio, OneDrive, Sharepoint and/or Adobe Acrobat Pro.
  5. Ability to research available literature and online resources regarding laboratory test methodology.
  6. Experience with FDA compliance regulations, particularly creating an audit trail.
  7. Familiarity with Eastern herbal medicine modalities.
  8. Experience using powered lifting equipment such as an electric pallet jack, walkie stacker, or forklift.
  9. Background in STEM (Science, Technology, Engineering and Math) work.

 

                                                                                                                                                                                                                                                                                                                                  

 

Skills Required

  • Associate's or Bachelor's degree, or equivalent education and experience, preferably in a science-related field
  • Good written and verbal communication skills and strong attention to detail
  • Proficiency in Microsoft Outlook, Word, and Excel
  • Good mathematics skills and familiarity with chemistry and biology terminology
  • Strong computer and technology literacy, with the ability to learn data-tracking software
  • Willingness to maintain individual and team accountability and accept constructive criticism
  • 20/20 vision or corrected vision
  • One year of experience in Quality Control, Quality Assurance, and/or Research and Development
  • One year of experience in a GMP/GDP production environment
  • Experience with ERP software such as Microsoft Dynamics NAV
  • Proficiency in Microsoft PowerPoint, Visio, OneDrive, SharePoint, and/or Adobe Acrobat Pro
  • Ability to research laboratory test methodologies using literature and online resources
  • Experience with FDA compliance regulations, particularly audit-trail creation
  • Familiarity with Eastern herbal medicine modalities
  • Experience using powered lifting equipment, such as an electric pallet jack, walkie stacker, or forklift
  • STEM work background
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The Company
HQ: Scotts Valley, CA
278 Employees
Year Founded: 1978

What We Do

Established in 1978, Threshold Enterprises® is a wholesale distributor of dietary supplements and health care products to the natural foods industry and health care professionals as well as the parent company of Source Naturals® and Planetary Herbals® brand supplements. We are a top employer in Santa Cruz County, California. We welcome you to view our current openings in all areas of the Company. http://www.thresholdenterprises.com/employment/

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