- PRINCIPAL ACCOUNTABILITIES (SUMMARY)
- Reporting directly to the Total Quality Manager (TQM), this position uses critical thinking and technical writing skills to research, develop and document key quality processes such as process and software validations, procedures, risk assessments, PFMEAs, as assigned in a timely manner.
- This role supports all levels of operations, quality and engineering departments in the development, management and execution of testing and validation protocols. This position will service all aspects of the businesses at PCNA.
- This role creates and maintains the facilities’ master validation plan and equipment calibrations.
- Facilitates the company’s Management of Change (MOC) process.
- Maintain outgoing process data for statistical analyses, trending purposes to ensure the process is maintained as validated.
III. POSITION REQUIREMENTS
Education, Credentials, Licenses:
- Bachelor’s degree in Engineering (Biomedical, Mechanical, etc), Science (Chemistry, Biology, Physics, etc.), or Math (Statistics).
- Minimum of 5 years of experience in an industrial manufacturing environment with a quality system designed to meet the requirements of the FDA Quality System Regulation. GMP in Cosmetics or Pharmaceuticals a plus.
- Certifications in quality, engineering, Six Sigma, or Lean Manufacturing preferred.
Skills & Abilities:
- Strong English verbal and written communication skills.
- Strong skills in problem solving, technical writing and analytical thinking.
- Excellent Attention to Detail.
- Intermediate to Advanced skills in MS Office Applications.
- Excellent project and time management skills, including the ability to manage multiple overlapping projects and deadlines.
- Knowledge of ISO, FSMA, SQF, FDA, and QSR concepts and guidelines as well as national and international regulations and standards.
- Self-motivated, yet able to take assignments as directed.
IV. PERFORMANCE MEASURES AND STANDARDS
- Ensure that federal, state and local laws, regulations, rules and codes are observed.
- Develop timely validation and test protocols for new processes, computer software, or equipment in conjunction with the engineering group.
- Coordinate and manage all validation activities at the sites.
- Prepare reports and maintain records in accordance with Regulatory Standards.
- Interacting and presenting validation documentation during internal and external audits.
- Produce and perform risk assessments and PFMEA documents for the equipment and processes.
- Ensure that all training activities associated with validation activities are performed in a timely manner.
- Ensure all systems are running according to necessary specifications and operate within regulations to ensure the production of quality products.
- Partner with department leaders to execute validations in a timely manner.
- Ensure calibration activities outlined are done so in a manner consistent with standards.
- Initiate Management of Change (MOC) per requirements;
- Follow the hierarchy of controls for risk management;
- Support efforts to implement and maintain the all company certification and regulations including, SQF, ISO 9001, and RC14001/EHS&S management system;
- Conform with the EHS&S Policy and the Cardinal Rules;
- Maintaining a safe and secure workplace and meet environmental site requirements;
- Support the EHS&S and Quality objectives and targets, and any specific action plans or management programs assigned;
- Understand the EHS&S risks and impacts of the employee’s job and functional area, including appropriate controls and procedures;
- Understand the EHS&S impacts/consequence that could result if specified procedures are not followed;
- Report accidents and incidents to a supervisor or the EHS&S department;
- Participate in required EHS&S and Quality training.
- Other duties as assigned.