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Life Sciences Quality Specialist – REMOTE

GPAC

This is a Full-time position in Atlanta, GA posted November 9, 2021.

THIS IS A REMOTE POSITION

North America (NA) Customer Qualification Specialist
Reports to: Vice President, Regulatory, Product Stewardship & Quality

PRIMARY JOB FUNCTIONS:
* 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
* Participates in customer audits
* Completes customer questionnaires, qualifies customers, is first point of contact for quality assurance/regulatory inquiries. Liaison to quality/regulatory function

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.

CAREER-PATH OPTIONS:
With experience, depending on interests and training, NA Customer Qualification Specialist can aspire to, among other positions, the following:
* Commercial Function
* Global/Corporate Functional Groups;
* Quality Assurance Manager
* Senior Product Steward

ROLES AND RESPONSIBILITIES
DETAILS:
Customer
* 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 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 customer
* Gather customer feedback and share with Commercial, Quality and Regulatory teams
Regulatory
* 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
Quality
* 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 qualification improvement activities as appropriate to raise adoption of company’s product lines

QUALIFICATIONS:
NA 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

COMPETENCIES BEHAVIORAL INDICATORS
LEADERSHIP
Ability to take initiative and make decisions to achieve product quality objectives.
* Communicates clearly and effectively.
* Correctly evaluates the facts and unforeseen situations to make the best decisions.
* Supports and Sustains the ANGUS Management System and its supporting Internal Systems.
* Collaborative.
* Is proficient at negotiation and persuasion.
* Ability to address/influence a wide range of cultures, disciplines, and levels within the organization
* Is receptive with an open mind.
* Willing to work effectively in a matrix environment
* Establishes fruitful interpersonal relationships.
* Makes decisions within a regulatory context. DOCUMENT MANAGEMENT Ability to ensure compliance of controlled documents. * Cautiously analyzes data. * Verifies document completion for compliance with standards and specifications for pharmaceutical or biotechnology products. * Drafts reports within prescribed time frames and in accordance with customer requirements and regulations. * Approves required product qualifications packages.

PROBLEM SOLVING
Ability to implement relevant solutions to problems or situational changes.
* Ability to work across functions and pull groups together to complete projects
* Adopts a rigorous approach to problem solving within a regulatory context.
* Adapts to unforeseen situations.
* Assesses the urgency of situations, demonstrates independence, initiative and drive
* Makes realistic and appropriate decisions.
* Follows up on compliance issues until final resolution.
* Identifies and evaluates effective risk mitigation strategies QUALITY ASSURANCE AND REGULATORY COMPLIANCE

Ability to ensure compliance with good manufacturing practices and regulatory requirements. * Working knowledge of applicable Regulatory and Industry requirements, standards, and guidance such EU Cosmetics Regulation, Ecolabel etc… * Working knowledge of applicable Regulatory and Industry requirements, standards, and guidance such as IPEC, ISO, FDA, EMA, TGA, ICH, and PIC/s. * Judiciously identifies non-compliance situations. * Proposes realistic and relevant actions. * Ensures product integrity and compliance based on standards and regulations. * Complies with established timelines.

All qualified applicants will receive consideration without regard to race, age, color, sex (including pregnancy), religion, national origin, disability, sexual orientation, gender identity, marital status, military status, genetic information, or any other status protected by applicable laws or regulations.

GPAC (Growing People and Companies) is an award-winning search firm specializing in placing quality professionals within multiple industries across the United States for the past 31 years. We are extremely competitive, client-focused and realize that our value is in our ability to deliver the right solutions at the right time.


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