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.
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ResponsibilitiesÂ
- Accurately fill out batch records and raw material paperwork. Â Â
- Accurately fill out product release forms and generate Certificates of AnalysisÂ
- 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.Â
- Complete assigned daily, weekly, and monthly assigned lab duties. Â Â
- 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.Â
- 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. Â 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. Â
- Determine homogeneity of bulk on solubility checks. Â 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. Â 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)Â
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Minimum Education & ExperienceÂ
- High School Diploma or related experience.
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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. Â
- Good listening skills.
- Ability to read, write and speak English competently.Â
- Strong oral and written communication skills.Â
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Preferred Knowledge, Certifications, Skills & Abilities
- Ability to trouble-shoot basic instrumentation; FTIR, pH meters, viscometers, and scales.
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Travel & Working Conditions
- Primarily lab environment – climate controlled.
- Visits to:Â
- 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.
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