QC Lab Tech

Position Description

Conduct analytical tests for the purpose of the timely release of batches and approval of raw materials with adherence to good laboratory practices.

Responsibilities

• Accurately fill out batch records and raw material paperwork.
• Accurately fill out product release forms and generate Certificates of Analysis
• Monitor areas of responsibility for GMP and Safety violations on a continuous basis
• Perform GMP investigations and inspections.
• Conduct analytical testing on raw materials, bulk product, and finished product.
• Ensure regularly scheduled lab equipment checks and instrument maintenance is conducted and properly logged.
• Perform quality checks prior to the start of batches to ensure all chemicals are accounted for, in correct quantities, and that batching vessels are clean and sanitized prior to use.
• Communicate with other departments as needed to streamline the batching processes, raw chemical receiving processes, and production processes.
• Complete assigned daily, weekly, and monthly assigned lab duties.
• Maintain records and prepare reports and correspondence related to the work.
• Keep up to date with health/safety issues related to work.
• Communicate effectively with others.
• Maintain a good attendance record.
• Perform work onsite.
• Perform other duties as assigned
• Maintain Lab fully stocked with material as needed.
• Proficient with AS400, and Webdocs systems.
• Familiar with RedZone software.
• Perform work onsite.
• Perform other duties as assigned.
• Analyze samples from various sources to provide information on compounds or quantities of compounds present using analytical techniques and instrumentation.
• Create working lab solutions for lab use using established procedures
• Log incoming chemicals, document their usage and disposal for the lab using established procedures
• Interpret data and adhere to strict guidelines, instrumentation, and software.
• Report scientific results according to Standard Operating Procedure (SOP) guidelines.
• Interpret and report issues related to batching, raw chemicals, and production.
• Identify solutions to correct out of specification batches. Perform lab batching for out of specification batches, upscaling calculations, weigh, and measure out chemicals accurately.
• Use tank mixing controls, sampling techniques, and recirculation methods to ensure efficient mixing and batch homogeneity.
• Determine homogeneity of bulk on solubility checks. Be able to identify when additional mixing and recirculation is needed.
• Issue adjustments to batches following established procedures and guidelines.
• Perform small-scale adjustments (<50lbs, simple chemical additions) to batches.
• Work with production to perform analytical tests needed to help troubleshoot line issues.
• Liaison with R&D and Quality Management to communicate information about R&D batches, and problem batches.
• Ability to multitask and adjust priorities in relation to urgency and importance in a fast-paced production environment.
• Ability to complete adjustments according to pre-established procedures. Ability to properly document all required datapoints on adjustment sheet(s).
• Report GMP issues to Quality Management
• Work collaboratively in cross-functional teams.
• Liaise with staff, suppliers, and customers (internal and/or external).
• Ability to perform the tasks needed for external testing (documentation, POs, shipping)

Minimum Education & Experience

• High School Diploma or related experience.

Knowledge, Skills & Abilities

• Lab experience within the field.
• Experience with basic analytical tests such as ph, viscosity, and specific gravity.
• Familiarity with basic instrumentation; GC, spectrophotometers, pH meters.
• Proven ability to multitask.
• Good listening skills.
• Ability to read, write and speak English competently.
• Strong oral and written communication skills.

Preferred Knowledge, Certifications, Skills & Abilities

• Ability to trouble-shoot basic instrumentation; FTIR, pH meters, viscometers, and scales.

Travel & Working Conditions

• Primarily lab environment – climate controlled.
• Visits to:
  • Warehouse environment – some temperature extremes, dust, and noise.
  • Manufacturing environment - some temperature extremes, dust, noise and wet.
• Requires use of PPE such as safety glasses, hairnets, or gloves.
• Exposure to hazardous chemicals.