Position Summary

The Product Complaint Associate is an entry level position, providing support to the Product Complaint process. Primary responsibilities include carrying out laboratory work to assist the specialists in the investigation and closure of complaints within an FDA regulated environment. In addition, this position will also assist with testing survey samples, cross-over and validation panels. Position may also handle complaints, under the direction of Department Management and/or guidance of more senior staff. This position works under direct supervision to provide exceptional technical and customer service external and internal customers. Excellent Interpersonal and collaborative skills and teamwork are a strong requirement. Basic technical product knowledge is important to performing the role associated with this position to provide the best service to our customers.

Key Accountabilities

• Conducts laboratory testing to support investigations and customer inquiries, under the direction of senior staff and in accordance with Standard Operating Procedures (SOPs) and/or Work Instructions (Wis).
• Performs additional laboratory or other product complaint-related tasks, under the direction of department management, and in accordance with SOPs and/or WIs.
• Completes all documentation required for assigned work, including maintaining records in the company's enterprise resource planning (ERP) tool, SAP, in accordance with SOPs and good documentation practices (GDP).
• Collects and analyzes data, prepares reports, as required, to document complaint investigations and or projects.
• Works on a variety of department projects and assignments; provides observations, recommendations, and reports to management.
• Maintains work area in a clean and orderly manner.
• Monitors and maintains laboratory supplies and equipment, with approval of department management.
• Performs other duties and projects as assigned to meet department and company objectives.
• Complies with applicable Werfen standard operating procedures (SOPs), ISO 13485, FDA 21 CFR and other applicable Quality System regulations, as well as applicable Environmental Health & Safety, Human Resources and other regulatory and administrative policies.
• Reflects the values of Werfen in the quality of work and in working relationships.

Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.

Internal Networking/Key relationships

• Technical Support team
• Sales team
• Field Services team
• Global Systems Support team
• Manufacturing teams
• Regulatory Affairs team
• R&D teams, including MTS team
• Marketing team
• Werfen international Affiliates

Competencies

• Customer service and interpersonal skills
• Analytical skills
• Problem solving, judgement and decision making skills
• Strong written and verbal communication
• Good laboratory skills
• Solid understanding of Medical Device Reportability and Quality System Regulations

Minimum Education, Experience, Skills and Knowledge Education:

• Bachelor's degree in biological science, or related field, required

Experience:

• Experience working in a regulated life sciences environment strongly preferred.
• Medical device, IVD, autoimmunity related experience preferred.

Skills & Knowledge:

• Working knowledge of quality systems regulations preferred.
• Working knowledge of Microsoft Office suite and ERP systems, preferably SAP required.
• Proven ability to multi-task, work under pressure, adapt and thrive in a fast-paced customer support/call center environment strongly preferred.

Management has the discretion of substituting relevant work experience for a degree and/or making exceptions to the years of experience requirement.

Travel requirementsLess than 5%