Responsible for providing management of Quality systems and personnel for a Therapak site. Ensures staffing levels and work assignments meet facility requirements. Responsible for the administration of the Quality Assurance (QA) and Quality Control (QC) programs and ensures compliance with the Quality Manual, as well as, all applicable regulations and standards for which Therapak/VWR is certified.
MAJOR JOB DUTIES AND RESPONSIBILITIES (List in order of importance)
- Oversee and ensure Quality Assurance program, Quality Assurance leadership and associates. Attend to and guide inspections as required.
- Oversee systems that effect quality of product.
- Oversee product recalls.
- Provide support regarding the revision or implementation of the documentation of these systems, including procedures, work instructions, and forms.
- Direct CAPA program and support Lead Auditor to ensure CAPA and audit programs (internal and external) are sound.
- Lead customer audits, including audit preparation, documentation, follow-up, and closure.
- Conduct audits for Quality Management System (ISO/QSR).
- Support supplier evaluation program, including supplier audit program. Review program and advise Purchasing where issues exist.
- Oversee the application of business Quality Management Systems.
- Provide technical support regarding the revision or implementation of process documentation, including procedures, work instructions, and forms.
- Have working knowledge of and support compliance with ISO 9001, ISO 13485 and FDA Quality System Regulations (QSR).
- Evaluate and advise management on current regulations and standards, new regulations and/or standards and proposed changes. Provide enterprise-wide strategic insight to senior management.
- Maintain the integration of FDA regulations and ISO standards into the Quality Management System (QMS).
- Support and advise necessary continuous improvement projects as a result of periodic trend reporting; management review; complaint investigation; supplier, customer, and internal audits; and any other relevant quality event. Use Six Sigma and Lean Manufacturing methodology to drive quality system improvements.
- Create, implement, and maintain process improvements, key initiatives, projects, and tasks, as assigned.
- Direct implementation of QMS software system.
- Deploy effective root cause analysis enterprise-wide.
- Provide training as requested. Prepare, conduct, and advise necessary training on quality assurance concepts and tools.
- Consult with Sales on viability and capabilities of new products. Understand product workflow; follow product from start to finish, ensuring finished good meets written expectations/specifications. Review design process of finished goods as it relates to customer specifications.
- Lead Complaint Investigation efforts, including managing weekly meetings and reviewing prior to closure.
- Close or escalate complaints / CAPA inputs.
- Conduct periodic review of complaint process, audit program, and related quality programs.
- Support validation program.
- Coordinate and support ETQ Reliance Software based on Global Compliance Direction.
- Performs other duties as assigned.
QUALIFICATIONS (Education/Training, Experience and Certifications)
- Bachelor’s degree or equivalent/applicable experience
- 6-8+ years of related experience
- Experience working in a regulated industry (medical devices, API, pharmaceuticals, etc.) preferred
- 1-3 years of leadership responsibility
KNOWLEDGE SKILLS AND ABILITIES (Those necessary to perform the job competently)
- Good interpersonal and people management skills. Ability to lead and motivate personnel; and cultivate a team mentality
- Working knowledge of ISO 9001, ISO 13485 and FDA Quality System Regulations (QSR)
- Ability to interact with all levels of the organization
- Functional knowledge of Microsoft Outlook, Word, and Excel, (or equivalent), highly desired
- Previous exposure and experience with automated inventory control systems strongly recommended.
- Demonstrated knowledge and experience with software systems and integration with the quality system.
- Strong communication skills – verbal and written
- Demonstrated knowledge of production process and prioritization in one or more business units
- Ability to prioritize required functions, ensure on time completion of required tasks, and manage time effectively.
- Ability to liaise with different departments to ensure all business and process related tasks are compliant with regulatory requirements and daily Quality needs are met facility-wide
ENVIRONMENTAL WORKING CONDITIONS & PHYSICAL EFFORT (Under Typical Positions)
Works in an administrative area thermostatically controlled to room temperature with adequate lighting and ventilation.
May work a portion of the day on the production floor thermostatically controlled to room temperature with adequate lighting and ventilation and with occasional elevated noise levels. May work a portion of the day in a general warehouse environment with adequate lighting and ventilation with occasional elevated noise levels and a varying range of temperatures.
Work assignments are diversified. Examples of past precedent are used to resolve work problems. New alternatives may be developed to resolve problems.
A frequent volume of work and deadlines impose strain on routine basis.
Minimal physical effort is required; however, the job position does require frequent walking, standing, bending, reaching, lifting or possibly carrying objects weighing up to 30 lbs.
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.
Avantor is proud to be an equal opportunity employer.