Complaint Handling Specialist

2 weeks ago

Houston, United States Empower Pharmacy Full time

Position Summary:
As a Complaint Handling Specialist at Empower, you are more than just a crucial link in our quality chain; you are the catalyst for transformation, turning customer feedback into actionable insights and robust improvements. In this dynamic role, you will harness your investigative skills to delve into customer concerns, ensuring that every voice is not only heard but also acted upon with the utmost precision and care.

Tasked with the critical mission of upholding our standards, you will meticulously analyze and resolve customer complaints, craft detailed investigative reports, and ensure compliance with regulatory requirements by reporting adverse drug events directly to the appropriate state or federal agency. This role demands a sharp eye for detail, a firm commitment to accuracy, and a relentless pursuit of excellence.

Join our team and step into a role where your efforts are directly tied to enhancing product quality and customer trust. This is your opportunity to impact our continuous improvement processes and contribute significantly to our commitment to delivering high-quality, reliable products. Here, every challenge is a chance to innovate and every day brings an opportunity to excel.

Duties and Responsibilities:

- Leads activities in handling Customer complaints and conducting investigations, product Quality and Adverse Drug Events (ADE) complaints and investigations, ADE reporting, and trending complaint data.
- Responsible for area SOPs.
- Responsible for submitting any reportable complaints to the FDA, including acting as the point of contact for FDA complaint follow-up.
- Tracks and trends complaints, ensuring they are closed promptly and integrated with other quality systems such as Biannual Product Reviews, NCIs, etc.
- Assists with clinical and product inquiries, as well as product-related incidents.
- Assists and collaborates with cross-functional teams on assigned duties or projects.
- Ensures all work is performed and documented promptly, according to approved SOPs, and complies with State Board of Pharmacy requirements.
- Demonstrates a high level of discretion in timely identifying and resolving events that could potentially impact the quality of products and processes.
- Follows and encourages safety and appropriate regulatory guidelines.
- Performs other duties as assigned.

To succeed in this job, an individual must be able to satisfactorily perform each essential function. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodation may be made to enable qualified individuals with disabilities to perform the essential functions.

While performing the job responsibilities, the employee is required to talk and listen. The employee is often required to remain stationary for a significant amount of the workday and frequently use their hands and fingers to handle or feel to access, input, and retrieve information from the computer and other office productivity devices. The employee must regularly move about the office and around the corporate campus. The employee is occasionally required to stand, walk, reach with arms and hands, climb or balance, and stoop, kneel, crouch, or crawl. Visual abilities required by this job include close vision.

Knowledge and Skills:

- Strong technical writing skills are required.
- Knowledge of pharmaceutical manufacturing/controls.
- Ability to work autonomously within established procedures.
- Working knowledge of pharmaceutical regulations (USP, cGMP).
- Proficient in Microsoft Office skills, such as Excel, Word, PowerPoint, and Outlook.

**Key Competencies**
- Customer Focus: Ability to build strong customer relationships and deliver customer-centric solutions.
- Optimizes Work Processes: Knows the most effective and efficient processes for completing tasks, focusing on continuous improvement.
- Collaborates: Builds partnerships and works collaboratively with others to meet shared objectives.
- Resourcefulness: Secures and deploys resources effectively and efficiently.
- Manages Complexity: Makes sense of complex, high-quality, and sometimes contradictory information to solve problems effectively.
- Ensures Accountability: Holds self and others accountable to meet commitment.
- Situational Adaptability: Adapts approach and demeanor in real time to match the shifting demands of different situations.
- Communicates Effectively: Develops and delivers multi-mode communications that clearly understand different audiences' unique needs.

Experience and Qualifications:

- A bachelor’s degree in a technical or scientific discipline or equivalent experience is required.
- Previous experience with sterile drug manufacturing operations is required. Industry experience in non-sterile pharmacy or manufacturing operations, terminal sterilization of finished goods, 503A Compounding Pharmacy, 503B Outsourcing Facility, sterile finished dosage forms (IV bags, syringes, vials, pell

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