Quality Control Laboratory Manager-Hemostasis and Chromogenix

Overview:

Werfen

Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong.

Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. Were passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care.

Position Summary:

The QC Lab Manager is responsible for overseeing the day-to-day activities of multiple QC laboratory operations for the Hemostasis and Chromogenix teams, works to ensure standard quality, productivity and overall efficiency are maintained and/or improved within the laboratory. The QC Lab Manager works with cross functional teams to resolve product performance issues and investigations and will lead the department staff in support of QC lab activities, department goals and overall compliance.

Key Accountabilities

Essential Functions:

• Develop and maintain schedule/process to ensure product release dates are met, and production schedules are maintained and able to handle increases; escalate awareness of anticipated
• Participate on cross-functional teams in support of business goals and objectives; Coordinate appropriate process validation and customer complaint investigation. Interact with senior management regularly.
• Provide direction for QC lab testing and activities including a broad range of bench test procedures used in raw material qualification, testing of finished goods prior to release, the investigations of product performance and the conduct of routine validation studies.
• Maintain and monitor QC instruments/software, International Standard, QC House Standard reagent/controls, reference and test materials. Provide recommendations to upgrade QC instrument/software and technology.
• Work cross-functionally to resolve product performance or QC test issues. Work with Formulation team to address bulk issues, reduce in process scrap and improve lot to lot consistancy.
• Ensure all QC lab data and the respective laboratory QC databases, Statistical Process Contorl (SPC) are maintained and monitored according to applicable standards and Maintain up-to-date Quality Control Monograph (QCM), QC data templates, Standard Operating Procedures (SOP), and Raw Material Monograph (RMM).
• Identify and troubleshoot concerns; monitor product performance trend, equipment, and staff performance to resolve matters and escalate major concerns/problems as necessary quickly and efficiently. Initiate Change Order, Incident Report, memo and Non-Conforming Reports (NCR). Coordinate Corrective Actions.
• Manipulate and analyze data to provide metrics and communicate trends. Analyze this data to identify/investigate quality
• Identify department training needs and implement appropriate training measures; mentor and train staff to enhance both individual and department
• Always ensure safe working conditions throughout the department and ensuring adherence to all safety policies and procedures; work with management to identify and address safety matters and
• Ensure and maintain compliance with the companys quality system requirements through training and adherence to policies, procedures, and
• Continually evaluate performance of direct reports; take appropriate disciplinary action in accordance with company policy, as necessary.
• Perform special assignments or other duties as directed by Supervisor/Sr.Mangement.

Internal Networking/Key Relationships:

• Provide recommendations and cross over data to House Standard committee for selecting QC House Standard reagents and controls. Interect with WHO reference laboratories for QC House Standard value assignments.
• Managing QC activities in participation of quality control survey, such as CAP and UK NEQAS. Review survey report, monitor and report product performance trend/issue to senior management.

Skills & Capabilities:

• Strong understanding of GMP, Good Laboratory Practices (GLP), FDA/ISO/BSI, Quality System Regulations (QSR) is required
• Demonstrated ability to organize complex work assignments and oversee technologists to complete tasks and projects on time.
• Experience in developing laboratory SOPs and revisions according to regulatory guidelines
• Solid knowledge of all laboratory equipment /QC instrument.
• In depth Proficiency with common laboratory techniques, such as pipetting and use of balances.
• Demonstrated thorough knowledge of QC testing procedures required.
• Technical experience and judgment are called upon during investigation and daily interpretation of analytical results.
• Must possess strong investigational skills to determine root cause and identify and implement effective correction actions.
• Effective technical writing skills, including ability to write protocols, test procedures and other technical reports and documents.
• Previous regulatory audit experience a plus

Werfen People Manager Competencies: (applicable if in a People Manager Position)

The following competencies form part of the competency model for People Manager at Werfen and form part of our mindset around People Management and Leadership. We expect all People Managers of Werfen not only to demonstrate, but also to constantly continue to develop, the following competencies:

• Building Talent: Planning and supporting the development of individuals knowledge, skills, and abilities so that they can fulfill current or future job responsibilities more effectively.
• Customer Focus: Ensuring that the internal or external customers perspective is a driving force behind strategic priorities, business decisions, organizational processes, and individual activities, crafting and implementing service practices that meet customers and own organizations needs? promoting and operationalizing customer service as a value.
• Decision Making: Identifying and understanding problems and opportunities by gathering, analyzing, and interpreting quantitative and qualitative information? choosing the best course of action by establishing clear decision criteria, generating and evaluating alternatives, and making timely decisions? taking action that is consistent with available facts and constraints and optimizes probable consequences.
• Driving for Results: Setting high goals for personal and group accomplishment? using measurement methods to monitor progress toward goals? tenaciously working to meet or exceed goals while deriving satisfaction from that achievement and continuous improvement.
• Driving Innovation: Creating an environment (culture) that inspires people to generate novel solutions with measurable value for existing and potential customers (internal or external) ? encouraging experimentation with new ways to solve work problems and seize opportunities that result in unique and differentiated solutions.
• Emotional Intelligence Essentials: Establishing and sustaining trusting relationships by accurately perceiving and interpreting own and others emotions and behavior? leveraging insights to effectively manage own responses so that ones behavior matches ones values and delivers intended results.

People Manager Accountabilities:

Effectively carries out the expectations of Werfen People Managers as defined in Werfens Role of the Manager program. Among others this includes maintaining regular, at minimum once a month, and transparent communication with the team through effective use of formal one-on-one meetings with direct reports and team meets. Managing performance issues and conflict proactively; uses judgement in consulting with department leadership and Human Resources. Responsibility for the teams compliance in terms of training, and fulfilment of their tasks and objectives as well as onboarding of new employees and development of the existing team.

Min Knowledge & Experience Required for the Position:

• A Bachelors degree in life sciences, or Certified Medical Technologist (MT)/Medical Laboratory Scientist (MLS).
• A minimum of 10 years progressive Quality Control experience within a Good Manufacturing Practice (GMP) lab setting required; experience within a regulated medical device manufacturing or In-Vitro Diagnostic Device (IVDD) is a plus.
• Minimum of five (5) years of previous lead or supervisory experience, including experience with staffing and time management.

Travel Requirements: