Quality Assurance Engineer/Complaint Coordinator
- Job Title
- Quality Assurance Engineer/Complaint Coordinator
- Job ID
- CARROLLTON, TX 75006-6623
- Other Location
Swiss American CDMO LLC is a topical drug and medical device manufacturing company founded to provide cutting-edge topical skincare technologies to selected markets. Our business strategy consists of development, manufacturing and superior customer service to contract manufacturing customers worldwide. A strong team approach to serve our customers is the basis of our mantra – “Partnering to deliver service through quality, integrity, and commitment”. Are you passionate about Service Excellence, Results, Integrity and Leadership? These are the core attributes we are looking for at Swiss-American CDMO, LLC.
Quality Assurance Engineer / Complaint Coordinator
The Quality Assurance Engineer/Complaint Coordinator will maintain the Quality Assurance activities required for Swiss American CDMO (SA). This individual will be responsible for reviewing and managing cases in the complaint handling system for completeness, compliance, and accuracy. Additionally, the individual will be writing formal responses and communicating with customers (product owners). This includes but is not limited to process/product/equipment/Sterilization validations, quality system activities both internal and external to site, design control quality assurance activities and provides investigational support for NCRs, CAPAs and change management activities.
Essential Duties and Responsibilities include the following:
- Support product development by assisting the Engineering, Supply Chain, Operations and contract manufacture groups as a team player with an occasional role as the team lead in projects.
- Daily monitoring and follow-up on complaints and overall monitoring of initiation, investigation, and approval of complaint records.
- Coordinate responses to failures including next steps, CAPA decision, report ability decision, and trend analysis.
- Maintain knowledge; understand cGMPs and current regulatory expectations regarding complaint handling and reporting, trend analysis and overall Quality Systems.
- Lead and initiate communication to ensure quick responses to field complaints on a timely basis.
- Track and analyze field complaints to help resolve problems and improve the complaint handling process.
- Assuring complaint files are completed per the current process/SOP, timely evaluation of complaints within guidelines for the Quality Department and required regulations and standards are met.
- Processing bio-hazard materials while working with proper personal protective equipment.
- Interface with laboratory, manufacturing, shipping and purchasing areas regarding customer requests and inquiries.
- Maintain effective communication with outside salespersons and customers to assure timely and accurate details regarding complaints and problems.
- Assuring GMP and Quality System compliance by revising our validation, supplier quality, and quality systems procedures as required by our standard operating procedure.
- Effectively utilize several root cause analysis, data analysis and problem solving techniques such as 6M, Fishbone, Is/Is Not, 5WHYs, Statistical analysis with Qualitative and Quantitative data (variable and attribute data sets), Process Control Charts, Standard Deviation, Statistical Sampling Plans and AQL criteria as well as risk assessment methodologies etc.
- Interfacing with customers, suppliers and other internal personnel to perform the required implementation of Corrective and Preventive actions when necessary.
- Issuing periodic reports by developing plans for collecting, summarizing and reporting on complaint rates, quality system activities.
- Initiating product retention request to quarantine component/product in conjunction with the Quality Management team per applicable procedure.
- Effectively utilize SA software (uniPoint, ProcessPro, Laserfiche etc), statistical techniques, and tracking/trending tools (e.g. Excel, Word, Pivot Tables, PowerPoint, Project Management tools) to collect and analyze data (electronic and manual), create charts and trend reports, create PowerPoint presentations on performance as well as effectively present the data analysis.
Manage and participate in Quality System activities such as:
- GMP training for new and existing employees.
- GMP awareness program.
- Promotion of the quality system and compliance expectations.
- Compliance to domestic and international regulations, standards and guidance, customer requirements.
- Manage and participate in the Internal and External Audit programs by conducting audits, writing audit reports, distribution of reports and associated non-conformances, follow-up on designated timelines, etc.
- Acting as a team player completing other duties as requested by the Quality Manager or as needed to facilitate the goals for the organization.
- Assisting contract customers as required to perform Quality or Quality Engineering support on projects.
- Acts as support for site and vendor third party audits (FDA, Notified body, EPA, State etc).
- Acts as an internal reviewer on Quality systems, specs and change control.
- Comply with site procedures, cGMPs and Good Documentation Practices.
- Other Job Functions.
- Maintaining positive relations between Quality Assurance and all other functional areas.
- 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 may be made to enable individuals with disabilities to perform the essential functions.
- Bachelor's degree (B. A.) from a four-year college or university preferably in a Science discipline; or minimum three years of relevant experience in complaint handling or equivalent compliance experience; or equivalent combination of education and experience.
- To perform this job successfully, an individual should have knowledge of Microsoft Office Business Suite; Inventory software; Internet software and Manufacturing software.
We value our employees’ time and efforts. Our commitment to your success is enhanced by our competitive annual salary, an extensive benefits package including paid time off, medical, dental and vision benefits, 401K plan with company match and future growth opportunities within the company. Plus, we work to maintain the best possible environment for our employees, where people can learn and grow with the company. We strive to provide a collaborative, creative environment where each person feels encouraged to contribute to our processes, decisions, planning, and culture.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.