First Quality was founded in 1989 and, in nearly three decades, has grown to be a global privately held company with over 4,000 employees. Its corporate offices are located in Great Neck, New York, with manufacturing facilities and offices in Pennsylvania, South Carolina, Georgia, and Canada. First Quality is a diversified family of companies manufacturing consumer products ranging from Absorbent Hygiene (adult incontinence, feminine care, and baby care), Tissue (bath and towel), and Industrial (print and packaging materials), serving institutional and retail markets throughout the world. First Quality focuses on private label and branded product lines.
Our core business philosophy is built on a proud culture driven by safety and quality, respect, humility, integrity, customer focus, and teamwork. With leading edge manufacturing technologies and processes and visionary leadership, First Quality is positioned to continue significant growth in the coming years. We are looking for an experienced Chemist for our state-of-the-art manufacturing facilities located in McElhattan, PA.
This position is responsible for the implementation, compliance, and maintenance of quality system operations. To continually provide ideas to further strengthen the current Quality System and ways to integrate them into the manufacturing process. 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 according to procedures.
- Participates in the calibration of specific tooling purchased by FQP.
- 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 execute 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.
- Manages laboratory staffing, supplies and scheduling.
- Leads 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 and for regulatory compliance.
- 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 regarding raw materials and finished goods.
- Assists Quality Manager in establishing, implementing, and maintaining the Quality Management System.
- Observes all safety rules and uses the proper safety equipment at all times.
- Performs other duties as necessary when directed to do so.
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 a manufacturing environment.
- Experience with Microsoft Office (specifically Outlook & Excel)
- Excellent oral and written communication skills, computer skills, reasoning, and mathematical skills.
- Strong analytical and problem-solving skills
- Strong interpersonal and cross-functional team skills
- Must be able to work in a fast-paced environment.
- Demonstrated team leadership skills.
Excellent compensation and benefits, which are effective the first day of employment!
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.
