Chemist II

First Quality•Mcelhattan, PA

About The Position

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 First Quality is committed to protecting information under the care of First Quality Enterprises commensurate with leading industry standards and applicable regulations. As such, First Quality provides at least annual training regarding data privacy and security to employees who, as a result of their role specifications, may come in to contact with sensitive data. First Quality is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, sexual orientation, gender identification, or protected Veteran status. Founded over 35 years ago, First Quality is a family-owned company that has grown from a small business in McElhattan, Pennsylvania into a group of companies, employing over 5,000 team members, while maintaining our family values and entrepreneurial spirit. With corporate offices in New York and Pennsylvania and 8 manufacturing campuses across the U.S. and Canada, the companies within the First Quality group produce high-quality personal care and household products for large retailers and healthcare organizations. Our personal care and household product portfolio includes baby diapers, wipes, feminine pads, paper towels, bath tissue, adult incontinence products, laundry detergents, fabric finishers, and dishwash solutions. In addition, we manufacture certain raw materials and components used in the manufacturing of these products, including flexible print and packaging solutions. Guided by our values of humility, unity, and integrity, we leverage advanced technology and innovation to drive growth and create new opportunities. At First Quality, you’ll find a collaborative environment focused on continuous learning, professional development, and our mission to Make Things Better®.

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
Experience with aseptic techniques.

Responsibilities

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.
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.
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.