QA SPECIALIST - Now Hiring

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned. Manages internal audit program, CAPA, Quality and Food Safety change management process as it relates to new products, equipment or process. Maintains the site’s Food Safety Plan, HACCP and pest control programs. Assists Training Manager with cGMP training, including mapping out training plans, designing and developing training programs. Trains others in the process and maintenance of training records. Monitors process indicators and assures central data collection related to quality certifications and management system. Responsible for ensuring facility’s SOPs are aligned with 21 CFR Part 110, 111 and 117 regulations as it pertains to quality systems, pest control, and documentation of training. Along with area supervisors, performs daily audits of each production area using pre-established checklist of work area set-up to ensure work is performed in accordance with SOP. Logs findings, compiles report of findings and identifies corrective action required. Follows up with Production/Maintenance personnel on corrective actions to ensure timely closure. Provides findings and corrective actions to Quality Management for review and approval. Creates, updates and maintains monthly spreadsheet of the non-conformities that are observed during daily audits. Reviews with area management. Monitors temperature and humidity chart recorder to ensure charts are calibrated and maintained as needed. Documents investigations related to nonconformance related to chart recorders. Serves as facility liaison for external pest control provider, contacts area management for the corrective actions and provides reports to Compliance Management. Reviews facility calibration records for all production and lab equipment. Acts as SQF Practitioner. Assists with the development, implementation, review and maintenance of the SQF system, including food safety fundamentals and food safety plan. Takes appropriate action to ensure the integrity of the SQF system and communicates to all relevant personnel all information essential to ensure the effective implementation and maintenance of the SQF system. Performs new hire orientation training per schedule. Complies with safety and GMP requirements. SAFETY STATEMENT RESPONSIBILITY Supports a culture of safe production and operations; follows all safety rules and procedures. Actively participates in the safety program by: engaging in training activities to learn what constitutes a safety hazard; reporting safety concerns to the supervisor, submitting safety suggestions, and correcting or reporting to the appropriate people when an employee sees a workplace health or safety hazard, until it is resolved. Assists with communicating safety information to new employees. Fulfills responsibilities as outlined in the company safety management plan. QUALIFICATIONS To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions. EDUCATION and/or EXPERIENCE Bachelor’s degree from a four (4) year college or university. A minimum of four (4) years’ experience in Quality Assurance or Quality Control (preferably in the dietary supplement, food, or pharmaceutical industries) or an equivalent combination of education and experience. Minimum of two (2) years’ experience in root cause analysis. Knowledge of GMPs required. COMPENTENCIES Ability to organize workload and multi-task to ensure all tasks are completed on time. Intermediate experience with electronic documentation management system software is preferred. Proficient in Microsoft Office (Word, Excel, PowerPoint). Excellent written and verbal communications skills. Ability to write routine reports and correspondence. Ability to speak and write effectively. Exemplary mathematical and analytical skills. Ability to work with mathematical concepts such as probability and statistical inference. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations. Ability to read and interpret documents such as interpret general technical procedures, legal and/or governmental regulations. Ability to learn quickly, work independently, and assume responsibility for new tasks in a rapidly growing and changing company. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. Must be a self-starter and be able to handle multiple tasks, and able to communicate and work with others to complete assigned tasks. Familiar with lab and document management systems, such as LabVantange LIMS and ETQ Reliance is a plus. PHYSICAL DEMANDS The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to work at a desk and enter information into a computer. The employee frequently is required to use a computer and keyboard and to communicate in person and by telephone. While performing the duties of this job, the employee is required to read/review written documentation for extended periods of time. Specific vision requirements for this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus. Occasionally, the incumbent may be required to lift up to up to 25 lbs., and be able to walk, stand, reach and stoop. WORK ENVIRONMENT The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. As required, works in a loud area that requires hearing protection and other protective equipment to be worn. Works around ingredients such as vitamins, minerals, amino acids, botanicals, etc. and chemicals such as alcohol, that may require respiratory protection. May be exposed to potentially hazardous chemicals and biological materials. Intermittently exposed to vapors, airborne particles and/or herbal aromas. Intermittently exposed to all of the FDA designated major food allergens (Milk, Eggs, Fish, Crustacean shellfish (e.g. crab, lobster, shrimp), Tree nuts (e.g., almonds, walnuts, pecans), Wheat, Soybeans, and Sesame except for peanuts. 15-20% travel, including travel by plane, may be required. Must be able to work a flexible schedule, including off shifts and weekends.