"Lighting a Path to the Future"


Location: Austin, TX
Job Type: Contract
Hourly: $25.00 - $30.00
Date: 2/10/2018
Job ID: 02564956
Job Description
Top Tier Global Pharmaceutical company is expanding their Austin, Texas location
$25-30/hour on w-2 with full benefits

For the perfect fit for the level III position, it would be someone who also possesses the below mentioned level II experience, with possible experience as a supervisor. (This role is an introductory lead/supervisor position who will oversee the work that the two level II specialists will be producing). Furthermore, previous experience interacting with sites of manufacture. This individual will have ongoing communications with the sites regarding the investigation results and request that further investigations be conducted. 

Level II position would have experience in the Pharmaceutical complaint handling departments, while operating under SOPs, and abiding by the regulations set in place by the FDA. They would be able to review and analyze complaint investigation results, strong skills in grammar, sentence structure, etc. This means that they are not the ones actually conducting the testing but reviewing the actual investigation findings. 

These positions are newly created. This function did not exist prior to our new quality system. 

The original intake team is comprised of 8 individuals. These individuals handle all the product quality complaints for the United States. The team of 8 is responsible for answering the phone and entering complaints into the system, conducting follow up, compensation, replacements, etc. 

The processing unit (3 contingent workers) will be responsible for processing the cases that are entered into the system from the intake team. This means they will read over the case and ensure all components are filled out correctly and ready for the site to conduct their investigation. Once the investigation is complete, they will receive the investigation results and they will have to read them over and ensure the sites are adhering to FDA regulations in regards to conducting a full and proper investigation. This is why it is important for the potential candidates to have background experience in Pharmaceutical handling because they will be aware of the policies from the FDA. Once the processing team has decided that the investigation was adequate, they will close out the case. The candidate will possess strong analytical skills and high attention to detail. The Processing team will have interactions with two of our sites of manufactures. This new group of three will be the only processing unit for the United States and they will have interactions with the group of 8 along with 2 sites of manufactures. 

Under direct supervision, provides support to the department supervisor as a team leader and subject matter expert in a variety of complex duties associated with managing product complaints and supporting patients/customers associated with Company pharmaceutical, biologics, and combination products. The Quality Specialist III will initiate, own, processes, maintain, and conclude complaint files including determination of the appropriate investigation team based on manufacturing/packaging site and complaint type and nature. Results of the investigation will be incorporated into the complaint record and the Quality Specialist III will determine the appropriate root cause, conclusion, and action plan based on the investigative findings. This includes facilitation of product replacement and reimbursement as needed. Additionally, the Quality Specialist III will assist in monitoring intake and processing workloads and timelines. 

Key Duties and Responsibilities: 
1. Initiate, evaluate, assess and maintain complaint files, following complaint handling internal procedures. Analyze information obtained and create children records to be assigned to the site of manufacture/packager. Critically think how the reported event is best processed and investigated based on the global Company structure. 
• Initiate and set up child records. Maintain and update Global TrackWise database. Record all complaint activity in both hard copy (when applicable) and TrackWise records. 
• Assess incoming documentation from intake group and ascertain compliance to product specification and/or intended use as indicated in the product labeling. Adverse event and off label usage complaints are to be reported to Pharmacovigilance. Combination events, such as Lack of Effectiveness, will be shared with both Product Quality and Pharmacovigilance. 
• Expedite shipments for Complaint Sample Retrieval. Maintain oversight on location of complaint sample to provide status to sites as requested. 
• Solicit investigation status updates directly from site of manufacture/packager and evaluate analysis results on all submitted records. 
• Collaborate with manufacturing sites, packaging sites, third party quality, and corporate quality to make and document appropriate regulatory decisions. 
• Advise site to initiate further complaint investigations, and provide any additional follow-up and communication pertinent to the product complaint as needed. 
• Track and control files sent to site of manufacture/packager for investigation and complete necessary documentation and monitor timelines. 
• Evaluate Complaint Investigation results, and close records when all requirements are met. 
• Maintain a knowledge and understanding of current product labeling, other federal laws governing pharmaceutical complaints, Department of Transportation (DOT) requirements for complaint sample returns, and other global regulatory requirements as needed. 
• Process, evaluate and maintained files for reconciliation reports with various departments. 
2. Act as a Subject Matter Expert in department responsibilities and act as a team leader as needed. This includes: 
• Team oversight and guidance. 
• Monitoring of daily activities and team performance. 
• Monitoring of workload distribution, processing timelines, procedural/regulatory compliance, and overall record quality. 
• Support of global complaint processing as needed. 
• Collaboration with global Company colleagues. 
• Backup and delegate for the department supervisor. 
3. Develop, implement, and lead company, departmental and product knowledge as required: 
• Communicate and provide critical feedback and direction to a variety of departments such as Quality Assurance, Customer Relations, Operations, Marketing, Medical Information, Global Safety and Epidemiology departments, and Company/Third Party manufacturing/Packaging facilities, Physicians, Pharmacies, etc. 
• Handle sensitive conversations with patients and/or physicians, avoiding litigious or compromising issues, providing information, education and assurance to the patient and/or physician regarding product and service, effectively utilizing “talking points” and communicating corporate policy. 
4. Support and monitor department product reimbursement. 
• Ensure team is applying product reimbursement based on procedural and business guidelines 
• Inform internal and external customers of Company’s reimbursement policy and product return requirements. 
• Ability to monitor several cases at once, including status and follow-up as necessary. 
• Respond to verbal and written requests from internal and external customers for compensation of product quality complaints and adverse events. 
• Ability to identify potentially litigious customers, and forward to management for resolution.
5. Identify, initiate, and lead projects within the department. 
Projects may include: 
• Lead special projects as directed by department leadership 
• Write/revise department procedures as assigned. 
• Train new staff and conduct training/re-training on company policies, and departmental practices. 
• Assist in performing complaint audits. 
• Provide project and team leadership as needed. 
5. Participate in Regulatory Inspections and potentially directly interact with auditors during regulatory inspections. 

Minimum Requirements: 
Education and Experience 
Bachelor’s degree, with three to five years of previous experience in Quality, Regulatory, Clinical, and/or Customer Management (in a regulated environment) setting; or equivalent combination of education and experience. Previous leadership experience is preferred. 
Essential Skills and Abilities 
• Ability to act as a Subject Matter Expert in complaint management and customer interactions. 
• Ability to act as team leader associated with various department activities. 
• Ability to problem solve through vague and unclear information. 
• Ability to read, analyze, and interpret common scientific and technical journals, financial reports, medical reports, and legal documents. 
• Ability to respond to common inquires or complaints from customers, regulatory agencies, or members of the business community. 
• Ability to use word processing, spreadsheet, and database applications. Ability to learn various and multiple software programs. 
• Ability to handle confidential data in accordance with HIPAA and related international standards. 
• Ability to function in a controlled environment regulated by the FDA and other regulatory authorities. This encompasses knowledge of current regulatory requirements, guidelines, and interpretations. It also includes potential regulatory inspections participation. The specific requirements include, but may not be limited to: 
o ISO 13485:2016 and ISO 14971 
o FDA’s 21 CFR Part 211 and Part 314 (Drug Product Regulation), Part 600 and 606 (Biologics Product Regulation), 820 (Quality System Regulation), 803 (MDR Regulation), and Part 4 (Combination Product Regulation), and 21 CFR Part 11 (Electronic Records; Electronic Signatures) 
o Global regulatory requirements as needed 
• Knowledge of clinical, surgical techniques and procedures, and medical terminology. 
• Skill in demonstrating a professional phone manner. 
• Effective communication with physicians and nurses as required. 
• Expertise in complaint policies and requirements.


Newman-Johnson-King, Inc. & A H Justice Search Consultants • 862 S. Bay St. • Aransas Pass, TX 78336 • Phone: 361-758-2410
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