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Quality Assurance Laboratory Technician Lead
4 weeks ago
Position Title:
Quality Assurance/Lab Technician Lead
Function:
The Quality Assurance/Lab Technician Lead at Developlus Inc. ensures the consistent quality of production by developing and enforcing good manufacturing processes throughout the production process. Ensures company’s GMP compliance by visually and/or manually inspecting test products, before, during and after the production process including cleaning and sanitization processes. The Quality Assurance/Lab Technician will run and monitor inspection equipment, as well as record and analyze quality data which may include performing duties in the assembly line and laboratory as needed. The Quality Assurance/Lab Technician lead will report directly to the director of Quality.
Essential Duties and Key Responsibilities:
- Delegates work for the lab technicians and ensure assignments are completed in a timely manner.
- Comply with the established procedures, policies, and health and safety regulations.
- Assist product safety inspections, GMP’s, and IMS internal audits as required. Keep records and logs as appropriate.
- Assist and train on incoming inspection testing for raw materials. Testing and approving Bulk/Prefill samples, line clearances, in-process products, and finished products, as appropriate.
- Identify status and properly approve/reject material.
- Collects samples during production run for stability testing and retentions.
- Guides, instructs, and works with QC lab Techs on first articles approvals, product testing, and sample retention (retains) and all pertinent documentation.
- Perform QC lab Techs tasks as required or in absence of QC lab Techs. including covering shifts as required.
- Prepares quality documentation and reports by collecting, analyzing, and summarizing information and trends including, stability studies, re-work, corrective actions, and Deviations.
- Participates in the planning and support of the goals and objectives for the department.
- Establishes and maintains a safe environment by ensuring lab personnel adheres to procedures and policies and leads by example.
- Completes housekeeping around work areas.
- Calculate test results per established procedures.
- Ensure laboratory equipment is maintained and calibrated daily.
- Initiates nonconformance reports for items and/or processes not meeting specifications and requirements
- Maintains a variety of records related to quality control such as test results calibration logs, key performance indicators, etc.
- Keep the work area clean, safe and in an orderly fashion.
- Prioritize and handle multiple tasks simultaneously.
- Other tasks, projects, and assignments as needed.
Requirements:
- Experience in quality control, quality assurance, or adherence to policies and procedures that provide checks and balances within production processes.
- Strong organizational skills with great attention to detail and time management skills
- Thoroughly document and keep tract of work in a neat and organized matter.
- Flexibility to provide support to production as needed.
- Ability to work in a fast-paced environment commensurate with workload.
- Proficient in Computer skills such as Microsoft Word, Excel, Outlook, and ERP software.
- Ability and experience in studying the composition and properties of matter used in the development of hair color and other hair care products.
- Aptitude to keep matter of science such as measurement proportions, noting reactions, combining substances in search of new information or answers to new problems.
- Strong analytical skills to analyze data often used to conduct experiments.
- Critical thinking skills are needed to test solutions before developing the final version of a product.
- Proficient in titration, FTIR, spectroscopy, and physical chemistry tests.
- Proficient in equipment inspections and process validation.
- Stability studies, formula validation, and good lab practices.
- Collaborative teamwork.
Education/Experience:
- Bachelor’s degree in chemistry or any related scientific field or two years’ lab experience
- Strong background in laboratory skills and knowledge such as digital scales, glassware, pipettes. Erlenmeyer, burettes, beaker, etc.
- Must be able to perform ratio calculations.
- Minimum 2+ years of relevant quality laboratory and manufacturing experience (preferred).
Language Skills:
- Communication proficiency: ability to effectively communicate with employees at all levels as needed both verbally and in writing.
Mathematical Skills:
- Strong math skills, including algebra and ratio calculations.
- Complex problem-solving skills
- Familiarity with complex mathematical concepts
Reasoning Ability:
- Must be able to effectively communicate verbally and in writing.
- Strong time management skills
- Effective and efficient organizational skills
Physical Demands: While performing the duties of this job, the employee is regularly required to talk and hear. This position is mostly sedentary and requires repetitive hand movements, may require some standing, walking, bending, occasionally lifting 25-30 lbs., and filing throughout the workday. Specific vision abilities required by this job include close vision and the ability to work in front of a computer monitor for extended periods of the day.
Work Environment: While performing the duties of this job, the employee is frequently exposed to moving mechanical parts and vibration. The noise level in the work environment can be loud and is a fast-paced working environment and varying temperatures depending on the time of year.
Disclaimer: This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities, and activities may change, or new ones may be assigned.
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