|Document Control Specialist – Customer Complaints |
|Department: ||Quality/ Document/ Regulatory Control |
|Beginning Date: ||01/23/2012 |
|Closing Date: ||02/29/2012 |
|Location: ||Springville |
|Hours: ||Monday – Friday; 8:00 am – 5:00 pm |
|Salary: ||Hourly (DOE) |
|Supervision: || |
Managed by and works under the direction of the Assistant Quality Systems Manager and Director of Quality Management.
|Summary: || |
This position is responsible for assisting in the assurance document compliance in quality both domestically and foreign.
This position is also assists in providing a system of communication between Quality representatives in the Neways Foreign Offices and Neways Corporate Quality and other Neways Corporate Management as needed.
|Customer Complaint Duties: || |
- Maintain Rework/Customer Complaint and Effectiveness Checking logs and control all documentation for Customer Complaints and their investigations. Distribute files for Effectiveness Checks on the specific due dates.
- Conduct reconciliations, investigations, training, corrective action and effectiveness checking relating to customer complaints. Ensure all complaint investigations have been completed, signed and are correct.
- Review manufacturing and packaging batch records for deviations or observations related to customer complaints.
- Conduct and correspond with Customer Service, other Neways departments and foreign offices to receive and resolve customer complaints and possible product non-conformances. Inquire from the foreign offices inventory levels, sales rates, quantity of defective units, customer complaint history, inspection procedures and country regulatory requirements. Request product samples for investigational purposes.
- Work with QA to ensure returned products are properly retained for investigations.
- Inspect and review each returned product for any possible non-conformance or customer complaint.
- Document the review of each returned product and the product disposition.
- Maintain all investigation files and samples; hold them for an appropriate retention period.
- Dispose of investigation files after appropriate retention period has been met.
- Forward recommendations from investigations on product disposition/corrective action/effectiveness checking to Management for review and approval.
- Deliver copies of approved customer complaint responses to Customer Service and the foreign offices; Track notification to customers.
- Keep and maintain record of AER meeting minutes and documentation for all adverse reaction complaints.
- Conduct and correspond with Customer Service and a third party call center regarding Adverse Reaction complaints.
- Create and maintain customer complaint and adverse reaction trending graphs including monthly AERand customer complaint reports.
|Document Control Duties: || |
Review and forward appropriate release documents (Certificates of Analysis, Specifications, etc.) to foreign offices to facilitate the release of product for sale in each appropriate market/foreign office.
- Ensure that the appropriate MBCD (Manufacturing Batch Confirmation Document) is received and verified to be correct from each appropriate supplier.
- Assist in providing information and recommendations on non-conformances to the Material Review Board, taking and distributing meeting minutes, gathering information and assigning action items.
- Review Master Batch Records, Rework and Qualification Batch records for accuracy.
|General Duties: || |
Draft, revise and train on Standard Operating Procedures and documents for Document Control and Quality.
- Provide back-up responsibilities for other positions within Quality/Document Control.
- Work on regular and special projects assigned by Assistant Quality Systems Manager and/or Director of Quality Management.
|Requirements: || |
Must have immaculate attention to details and motivation to complete tasks thoroughly.
- Must be willing to learn and grow as the position expands.
- Must be able to analyze processes and suggest better ways of accomplishing tasks.
- Must be able to effectively communicate in written and verbal English.
- Must hold advanced level of composition and grammar skills.
- Must be able to make appropriate basic decisions where established procedures do not always apply, but be able to follow procedures closely when they exist.
- Experience with Microsoft* Office applications, especially Word and Excel (Access is a plus).
- Must be able to work efficiently with little supervision and deal effectively with stress caused by workload and time deadlines.
- Must be available at workstation a vast majority of the day; develop an effective working relationship with managers and fellow employees.
- Knowledge of the Guidance for Industry: Questions and Answers Regarding Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act and the Dietary Supplement and Nonprescription Drug Consumer Protection Act Dec 22, 2007
- Knowledge of 21 CFR Part 111 is desirable.
|Education ||Possess a high school diploma with one (1) year of specialized training provided through professionally sponsored workshops, seminars, in-service or on-the-job training and approximately two (2) years of related work or an equivalent combination of education and experience. |
|Work Environment: ||Incumbent of the position performs in a typical office setting with appropriate climate controls. Tasks require variety of physical activities, which may include; eye, hand, and wrist strain from frequent typing or other computer related tasks. Common eye, hand and finger dexterity required. Mental application utilizes memory for details, verbal instructions, emotional stability, discriminating thinking and guided problem solving.
How to Apply
Please fax or email resume to 801-418-2175 or firstname.lastname@example.org