Chemist II

Purpose and role of job:

Responsible for method development, validation, standard testing and non-routine testing using analytical testing equipment, including HPLC. Will work directly with Manufacturing, Product Development and Engineering to assure quality considerations are adequately covered in the design, testing, and release of materials, components and completed products on and off site.

Principal Accountabilities/ Responsibilities:

• Understands and performs quality testing according to approved procedures.
• Regularly reviews quality data to identify opportunity for corrective & preventive action.
• Ensures that statistical methods are applied to testing, validation, sampling and inspection activities and quality investigations.
• Participates in and leads teams in work related to improvement, new product development, cost savings, and other quality initiatives.
• Devises or revises procedures related to the Quality System.
• Ensures that all testing and measuring equipment is calibrated and maintained.
• Participates in the calibration of specific tooling purchased by FQ.
• Reports significant issues or developments identified during quality activities and provides recommended process improvements to management.
• Prepares and presents quality system information to team members.
• Develops and executes Equipment and Process Validations.
• Ability to operate, analyze results, trouble shoot and train on HPLC/UPLC testing equipment.
• Develops and supports all aspects of raw material and finished goods trials.
• Manage laboratory staffing, supplies and scheduling.
• Lead any laboratory audit or laboratory audit certification programs.
• Experience with aseptic techniques.
• Provides leadership and technical support to Quality Technicians and Quality Specialists.
• Provides technical support to all production teams and supporting departments.
• Provides guidance and methodology for testing, capability analysis and SPC to support validation and regulatory compliance.
• Supports raw material and finished goods corrective/preventive actions through root cause analysis and DMAIC Principles.
• Leads and/or participate in supplier and internal audits.
• Supports raw material and finished goods nonconformance program.
• Develops and execute product/process risk assessments and failure mode effects analysis (FMEA) across raw materials and finished goods.
• Provides support for 3rd party testing as requested by customer service.
• Reviews regularly quality data to identify negative product/process trends to respond proactively using applicable quality tools and methods to drive continual improvement.
• Develops and reports company quality metrics to management and production team members.
• Participates in laboratory/facility tours and provides Quality System explanations to visitors.
• Participates in the development of Standard Operating Procedures, Work Instructions, Calibration Plans, Inspections, Testing, Statistics, Sampling Plans, Risk Assessments, and others in regard to raw materials and finished goods.
• Assists Quality Manager in establishing, implementing, and maintaining the QMS.

Education and experience requirements:

• Bachelor’s degree in chemistry and four or more years of testing in an analytical laboratory using HPLC/UPLC equipment OR Bachelor’s degree in a scientific/technical field with eight or more years’ experience testing using HPLC or UPLC equipment.
• Strong knowledge of Quality Management Systems, ISO 13485/9001 or 22716 and FDA CFR.
• Sound knowledge of Validation (IQ/OQ/PQ), root cause analysis and implementation of corrective/preventive action in a manufacturing environment.
• Black Belt/Green Belt or Lean training
• Working knowledge of Quality Tools (i.e., FMEA, PDCA, DMAIC. Cause & Effect)
• Strong working knowledge with Minitab or similar statistical software relevant to manufacturing