Description
Quality Engineer (Pharmaceutical)
A established and growing company seeking a Quality Engineer with a background in the Pharmaceutical industry.
Job Responsibilities:
- Responsible for the development and administration of a Quality System compliant to FDA and ISO requirements.
- Responsible for the development and maintenance of compliant, optimal, cost-effective lean manufacturing processes and methods for new and existing projects including inspection, test and label control operations.
- Implement planned and systematic processes that support product quality.
- Responsible for validation activities, supplier evaluations, investigations, product dispositions and audits. Support continuous improvement through the use of appropriate tools, project leadership, and supporting internal and external customers.
- Perform internal quality system audits as lead auditor with guidance of senior staff.
Maintain customer complaint (CC) system per procedures. - Perform investigations, determine disposition of returned goods, determine re-inspection requirements, determine corrective and preventive actions (CAPA), issue complaint reports, complete customer CAPAs, and approve to close.
- Look for trends to determine actions to decrease number of CCs.
- Maintain Non-Conforming (NC) system per procedures.
- Perform investigations, participate in MRB (Material Review Board) activities, determine disposition, determine re-inspection requirement, determine CAPAs and approve to close.
- Look for trends to decrease number of NCs and provide feedback to management.
Maintain corrective and preventive action (CAPA) system per procedures. Initiate and perform root cause analysis. - Perform trend analysis and issue periodic report on quality systems for management review.
- Adhere to the company's Quality System (QS), write and approve QS documents.
- Work with company engineering, manufacturing, and inspection personnel on procedural problems involving design, methods, tooling, validations, costs, and other areas related to the control of product quality.
- Use statistical and capability analysis to solve problems.
- Communicate with customers on complaints, process changes, clarification of specifications, completing customer documents, and other projects as needed.
- Use Lean Enterprise methods to reduce waste and complexity in all processes.
- Establish inspections and sampling procedures to ensure the control of quality at the most economical costs.
- Write and approve protocols and reports.
- Approve Equipment Qualifications.
- Serve as project team leader on small projects. Schedule project activities and meet deadlines.
- Supervise QA Technician duties: assign tasks, review work.
- Train company personnel as needed in areas such as use of equipment, inspection methods, statistical methods, processes, and quality system.
- Act as integral member of the Quality group, in support of the defined Quality vision, values and goals.
Minimum Job Qualifications:
- Bachelors degree in Engineering or any relevant technical or science degree, or equivalent experience.
- 3-8 years pharmaceutical experience
- Strong written and verbal communication skills in the English language.
- Comprehensive understanding of applicable Work Instructions, QAPs, SOPS, and ISO standards
- Able to perform math functions, use statistical techniques (SPC, CpK, DOE, ANOVA)
- Demonstrated competence in using computer programs such as Word, Excel, PowerPointProject, Access, JMP or Minitab.
- Knowledgeable of lean manufacturing principles.