Production Lab Tech Lead

Your Role

Under direct supervision at our Spruce Site, the Production Lab Tech II performs technical duties in manufacturing, filling, labeling, packaging, shipping, and other lab-related tasks. Work is performed in accordance with standard operating procedures and includes basic laboratory techniques, calculations, material measurements, equipment operation, and record-keeping. Daily activities may also involve troubleshooting in SAP, supporting Dev/CAPA investigations, and maintaining lab cleanliness and safety.

Key responsibilities include verifying data, filling and labeling products according to the production plan, and using standardized methods. The role requires stocking inventory, adhering to safe lab practices, and supporting 6S Lean initiatives. The technician must comply with cGMP, FDA, OSHA, EPA, and Quality System regulations, and report any deviations to management. Additional duties include participating in failure investigations, attending meetings, composing professional emails, and presenting DMS Boards. The role follows site-specific standards such as MDSAP, ISO 13485, IVDR, and the site Quality Manual. Strong communication, customer service, and professionalism are essential. Specific responsibilities include:

• Perform area clearance tasks and maintaining separation of product
• Perform standard and new operating procedures
• Collect and record data on documents and batch records where required
• Utilize computer hardware and software for data entry and record keeping where required
• Ensure compliance with all Quality and Regulatory specifications
• Support process improvement through identification and reporting of areas needing improvement and assisting in improvement projects
• Effectively utilize Quality Management Systems (QMS) and other applicable databases
• Familiarity with and proper use of safety equipment and Personal Protective Equipment (PPE)

Who You Are

Minimum Qualifications:

• High school diploma or GED required
• 1+ years of within a production or manufacturing environment 

Preferred Qualifications:

• Working knowledge of SAP, SAP NEXT, or other ERP systems 
• Knowledge of GMP facility, FDA QSRs, and ISO 13485
• Experience in an FDA regulated biotechnology or pharmaceutical environment
• The ability to learn, understand, and carry out safe laboratory practices
• Proficiency with Quality Management Systems (QMS) 
• Knowledge of the metric systems
• Communicate effectively with all levels within the organization and with outside contacts