Location: Scotts Valley,CA, USA
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:
* 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.
* Interpret laboratory test results and supplier/ contract manufacturer documentation and evaluate them against established internal specifications for ingredients and finished products.
* Review and request information from suppliers as required on internal specification sheets and submit spec update requests as needed.
* Use the Enterprise Resource Planning (ERP) software, Microsoft Dynamics Navision, to track physical location, status, and ownership of materials in process.
* Investigate and recertify expired raw materials (ERMs) to extend expiration dates.
* Peer review Certificate of Analysis (CoA) packets for accuracy and Good Documentation Practices (GDP).
* Sort leftover sample materials into appropriate hazardous and non-hazardous waste streams.
* Assist other team members in learning and completing tasks as needed.
* 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.
* 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.
* Closely follow Safety and departmental SOPs.
* Provide support to internal audits and follow through with any corrective actions pertinent to the Quality Control Technical Analyst group.
* Perform all other tasks as assigned by Threshold management.
Qualifications
Minimum Qualifications Required:
* Associate's or Bachelor's degree or equivalent education and experience, preferably in a science-related field.
* Good written and verbal communication skills, with great attention to detail.
* Proficient in Microsoft Outlook, Word, and Excel.
* Good math skills and familiarity with general scientific terminology, particularly in chemistry and biology.
* Strong computer and technology literacy, and ability to learn various data tracking software programs.
* Willingness to maintain full self-accountability, accountability as a team, and to integrate constructive criticism.
* 20/20 or corrected vision.
Skills and/or Training Desired:
* 1 year of experience in Quality Control, Quality Assurance, and/or Research & Development.
* 1 year of experience in a GMP/GDP production environment.
* Experience with enterprise resource planning (ERP) software such as Microsoft Dynamics NAV.
* Proficient in Microsoft PowerPoint, Visio, OneDrive, Sharepoint and/or Adobe Acrobat Pro.
* Ability to research available literature and online resources regarding laboratory test methodology.
* Experience with FDA compliance regulations, particularly creating an audit trail.
* Familiarity with Eastern herbal medicine modalities.
* Experience using powered lifting equipment such as an electric pallet jack, walkie stacker, or forklift.
* Background in STEM (Science, Technology, Engineering and Math) work.