The Quality Assurance Associate is responsible to assist the QA Manager in all assigned Quality Management System activities and to ensure compliance to company requirements for candle manufacturing. Assist in developing, implementing and maintaining quality assurance processes within a Quality Management System structure. Overall responsibility includes document control, change control, root cause investigations, internal audit system oversight, production monitoring and other duties as assigned.
- Promote quality awareness throughout the organization.
- Ability to lead by example and mentor, coach and guide others of QMS requirements
- Responsible to maintain the Document Control function in accordance with company requirements. Responsibilities include organizing, controlling, tracking and maintaining documents, master SOP’s, forms, in electronic and hard copy format.
- Develops and maintains databases and spreadsheets using computer software to provide accurate and timely information needed to manage department services.
- Prepares reports, charts and other appropriate materials to support proposed changes and improvements.
- Examines documents for completeness and data accuracy and resolves discrepancies with document originators. May need to format documents to meet SOP or document requirements.
- Provide training on SOPs and other documentation as needed.
- Monitors and tracks training of new/revised SOPs and corrective actions.
- Write or revises procedures related to document control and other areas of functional responsibility.
- Identify product or process deficiencies and weaknesses in the interest of driving continuous improvements.
- Perform internal Quality System audits, report findings to management, and track completion of corrective and preventive actions.
- Perform effectiveness checks of completed corrective and preventive actions, as needed.
- Prepare trend analysis reports/graphs for CAPA, Internal Audit and NCR systems.
- Support ordering of office supplies
- Monitor daily production activities and provide compliance guidance and direction to production personnel.
- Ability to be flexible and contribute outside the assigned scope of responsibilities.
- Performs any other miscellaneous duties that may be assigned.
Knowledge and Background Requirements:
- Experience in a start-up company is preferred but not necessary
- Prefer 5 years’ experience working in a GMP regulated environment (food, Pharmaceutical or cosmetics) or ISO9001 certified company
- Knowledge of GMP, ISO 9001 or other regulated industry
- Must have proven proficiency in using Microsoft Office, including Word, Excel, PowerPoint
- Outstanding attention to details
- Bilingual in writing and speaking Spanish preferred
- Experience working within the framework of a Quality Management System which is subject to GMP and ISO requirements.
- Excellent communication and organizational skills
- Critical thinking and analytical skills
- Passion for driving continuous process improvement
- Demonstrated ability to prioritize tasks.
- Excellent interpersonal skills
- Experience with Document Control processes and other quality system processes
- Proficient in the review, formatting, analysis, proofing, and associated change process management of quality system documents to ensure that all documents meet the appropriate company procedures.
- Strong writing, quality review and editing skills
This is not necessarily an exhaustive list of responsibilities, skills, duties, requirements, efforts, or working conditions associate with the job. While this list is intended to be an accurate reflection of the current job, the Company reserves the right to revise the functions and duties of the job or to require that additional or different tasks be performed when circumstances change (i.e., emergencies, changes in personnel, work load, rush jobs, or technological developments).