Quality Assurance Product Complaint Specialist I - 1st Shift

Job Description

Job Description

SUMMARY  

Assists Quality Management in the investigation and resolution of customer complaints through all the reporting channels.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.

• Ensures product complaints are logged, investigated, and resolved according to established deadlines, company and GMP      requirements.
• Facilitates the testing of reserve or retain samples for investigation purposes.
• Communicates and provides support to Customer Service  and the Science Group as it relates to customer complaints.
• Creates detailed trend analysis reports showing product complaints by category and product. 
• Conducts root cause analysis sessions in order to  facilitate and initiate corrective and preventative actions with      manufacturing.
• Prepares formal reports for adverse event complaint responses to regulatory  authorities.
• Assists with documentation and investigation of  manufacturing deviations and non-conformances.
• Assists with GMP Training of quality and operations personnel.
• Assists with the management of document control system.
• Assists with regulatory audits.
• Completes pre-audit paperwork for customer audits.
• Compiles and submits monthly metrics reports.
• Complies  with safety and GMP requirements. 

SAFETY RESPONSIBILITY STATEMENT

Supports a culture of safety; follows all safety procedures. Responsible for safety performance in respective area. Ensures the implementation of, adherence to, and enforcement of workplace health and safety requirements. Ensures activities are completed to promote and enforce safe behaviors by supervisors and 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. 
• Minimum of five (5) years experience in Quality Assurance or Quality Control, in the food, pharmaceutical, dietary supplement, or medical device industries handling customer complaint issues or a combination of education and      experience. 
• Minimum of three (3) years experience in root cause analysis.
• Knowledge  of GMPs required.

• 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.  

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, some classified as allergens or irritants.
• 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 and  Soybeans, except for peanuts.
• Must be able to work a flexible schedule, including off shifts and weekends.