Customer Qualification Specialist
The Chatham Group
Our client, a leader in specialty chemistries is seeking a Qualification Specialist to ensure compliance with good manufacturing practices and regulatory requirements such EU Cosmetics Regulation, Ecolabel, etc… Thorough understanding of applicable Regulatory and Industry requirements, standards, and guidance such as IPEC, ISO, FDA, EMA, TGA, ICH, and PIC/s.
PRIMARY JOB FUNCTIONS:
- Works with sales team and customers to accelerate conversion to clients’ products
- Engages directly with customers to understand must have quality assurance/regulatory requirements
- Segments customers according to product quality assurance/regulatory requirements
- Educates customer/commercial on tangible product quality assurance requirements for product application
PRIMARY JOB FUNCTIONS & PROFESSIONAL ACUMEN:
- Computer System Proficiency: among other things, SAP and EXCEL, PowerPoint.
- Leads quality discussions between customer, commercial and quality/regulatory groups to ensure alignment and full understanding of customer quality assurance requirements
- Resolves customer quality assurance queries, recommend, and guide the appropriate options
- Create customer segments, develop, and implement quality assurance/regulatory requirements aligned to customer segmentation
- Participates and serves as customer liaison during audits
- Excellent communication skills that earn the trust of the customer and the commercial team, is a trusted partner for educating each on the relevant quality assurance requirements
- High degree of confidence to be able to say no to options that do not align with customer segmentation or requirements
- Establishes our reputation as a company that offers excellent customer support during the product qualification process
- Works effectively and fosters collaborative environment across the global teams to share knowledge, seek input to issues and develop shared accountability for meeting functional goals.
ROLES AND RESPONSIBILITIES DETAILS:
- Establish contact with their peers in our customers Quality organizations
- Respond to product qualification inquiries in a timely and accurate way, via phone, email, or in-person meetings
- Assist customers with the product qualification process
- Analyze and report any new or emerging customer needs as it relates to product quality assurance (e.g., different test methods, impurity profiles, etc.)
- Update internal databases with information about product quality assurance issues and ensure timely responses back to the customer
- Gather customer feedback and share with Commercial, Quality, and Regulatory teams
- Understands basic regulatory requirements for the region for each market segment and collaborates with business teams to support market expansions and new product introductions (product qualifications)
- Liaison with Regulatory to always have access to updated product literature related to regulatory compliance/claims
- Properly manages priorities according to deadlines
- Working knowledge of applicable Regulatory and Industry requirements, standards, and guidance such as IPEC, ISO, FDA, EMA, TGA, ICH, and PIC/s.
- Establishes quality assurance standards by studying product and customer requirements with members of commercial and quality functions.
- Actively assists in investigations into product-quality failure or non-compliance.
- Effectively partners with QA managers in order to implement corrective and preventative actions.
- Analyzes customers’ product specifications to establish efficient, cost-effective requirements for reproducibility
NA Regulatory Coordinator
- Works in partnership with the Responsible Care Team to execute corporate Responsible Care initiatives
- Maintains and tracks progress against the Product Stewardship Plan.
- Evaluates and modifies key performance indicators (KPIs) as needed
- Supports root-cause analysis and other problem-solving activities to identify corrective actions and process improvements.
- Initiates and implements product quality improvement activities as appropriate to raise adoption
Customer Qualifications Specialist(s) have:
- A Bachelor preferred, or education coupled with quality/regulatory certifications
- Experience with & understanding of Quality Management in the chemical and/or life sciences industry
- Two-five years of experience is desired.
- Previous work experience with chemical management regulatory bodies.
Employers are seeking candidates who possess the following skills:
- Ability to set priorities and work independently.
- Ability to work concurrently and manage multiple projects.
- Ability to work in a team environment.
- Analytical, problem solving, and synthesis skills.
- Flexibility and diplomacy in interpersonal relationships.
- Fluency in English (written and spoken).
- Proficiency in the use of common and specialized software.
- Ability to meet deadlines.
- Strong Communication skills.
- Ability to grasp new strategies and pathways