Basic Job Purpose:
Execute analytical and functional quality control test methods using standard laboratory equipment (e.g. spectrophotometer, Gas Chromatograph, electrophoresis equipment, pH meter, etc.) to evaluate quality and performance of reagents manufactured to defined specifications. Assist or perform other Quality Control (QC) department functions such as stability testing, testing of product returns or retains, validation studies, management of retained samples and instrument and equipment maintenance as directed.
- Inspect incoming, in-process and finished goods for compliance with established quality specifications. Work with manufacturing, receiving and materials personnel to complete required QC testing, documentation and status labeling in a timely manner. Update material status in inventory system as necessary.
- Perform laboratory testing such as analytical testing (e.g. pH, density measurement, spectrophotometry, gas chromotography), immunoassays (Western blot, ELISA) and cytological/histological testing (PrepStain, immunocytochemistry). Summarize and report results.
- Analyze data to specifications and designate as accept/reject. Initiate documentation for nonconforming materials as required.
- Prepare standards and control materials. Maintain documentation of preparation.
- Assist with management of retention materials, laboratory equipment maintenance and other projects as directed.
- Work with Manufacturing Technologies and New Product Development teams to inspect and test first article components and participate in validation studies.
- Assist with development of new and revised quality control specifications and methods.
- Execute post market stability program including writing protocols and reports and analyzing data and presenting results.
- Assist with testing of product returns and performing investigation of product complaints.
- Perform bioburden testing to defined procedures for monitoring of high purity water system.
- Ensure that equipment is cleaned and maintained according to work instructions.
- Assist with cross-training and mentoring of other technicians.
- Participate in continuous improvement activities (e.g. kaizen).
- Prepare, analyze, and distribute quality metrics (including SPC charts). Recommend action plans for unfavorable trends.
- May participate on extended core teams as a QA/QC representative.
- Handle hazardous waste as appropriate.
- Maintain 5S work area.
- Additional responsibilities as assigned by QA management.
- Operation of automated staining systems and other laboratory equipment.
- Good communication skills (written and oral) and the ability to work in a multidisciplinary team environment are essential.
- Must be able to prioritize, work independently, and complete tasks on schedule.
- Must be able to work with hazardous chemicals and biohazardous materials in a safe manner.
- Position requires occasional overtime as designated by Operations/Quality management. Overtime duties may be outside of direct area of responsibility.
- This position requires that the employee be present at designated shift start up times to ensure smooth production operation. Schedule may need to flex based on business needs. Position may require nontraditional work weeks such as 4/10 hour days.
Education and Experience Required:
Education and Experience Preferred:
- High school diploma/GED with a minimum of 3 years related laboratory experience. An Associate's or Bachelor's degree in an applicable field may substitute for 2 years experience.
- Experience with sampling techniques, inspection standards, or use of analytical laboratory equipment (e.g. spectrophotometer, Gas Chromatograph, pH meter)
- Excellent basic math skills and the ability to utilize Excel for basic calculations and graphing
- Ability to write technically and summarize information into data reports using Microsoft Word.
- Ability to lift up to 25 lbs unassisted
- Good attention to detail and the ability to work independently as well as in team situations
- Associate's degree or higher in quality or science related field
- Experience working in an FDA regulated environment (medical device or pharmaceutical industry)
- Knowledge of immunoassay testing
- Experience in histology or cytology slide preparation and imaging
- Knowledge of basic validation requirements or experience in performing method validations
- Knowledge of statistical techniques including use of data analysis programs such as Excel or Minitab and application of sampling plans
- Ability to design spreadsheets for QC applications
- Knowledge of SPC charts/development of metrics
- Knowledge of Lean Manufacturing/Continuous Improvement/Six Sigma
- 2 years ago - save job