Quality Control Analytical Supervisor

Job Description

Job Description

This position will report into the Manager of QC Analytical. The QC Analytical Supervisor will organize, and direct staff to meet and exceed cGMP requirements, and establish KPI’s, while adhering to quality control and technical standards. The QC Analytical Supervisor will also provide oversight of day to day activities including adjustment of workflow, test performance, and quality compliance.

• Ensures compliance with regulatory agency requirements by enforcing a quality culture throughout the department.
• Schedules and monitors daily operation of department based on projected client demands.
• Conducts routine walkthroughs of the facility to ensure compliance with regulatory and quality practices.
• Approval of investigations and documentation of non-confirming events and OOS.
• Recommends process improvements to achieve greater efficiency within the department and between sites.
• Participates in department and cross functional meetings.
• Maintains audit readiness within the department by ensuring proper training of staff, reviewing documentation, and ensuring laboratory cleanliness.
• Interacts with internal and external customers to ensure proper sampling, reporting, and resolution of questions and concerns.
• Direct reports: QC Analysts (Approximately 8-10 reports)
• Other duties as assigned.

REQUIREMENTS

• BS degree in Science or relevant field;
• 7+ years of experience with analytical laboratory or within the biopharmaceutical industry or equivalent.
• Strong knowledge of FDA and EU regulatory standards. cGMP experience required.
• Strong knowledge of analytical test methods and philosophies.
• Strong knowledge of quality systems and ability to interpret Quality standards of implementation and review.
• Proficient with computer software with MS Office and LIMS
• Competencies/Candidate Profile
• Acts decisively
• Exercises good judgment and makes effective, sound, timely and informed decisions. Seeks to identify, analyze and resolve problems effectively.
• Builds and maintains relationships
• Strong collaborative and influencing skills and ability to work well in a matrixed environment with internal and external stakeholders.
• Communicates effectively
• Uses appropriate modes and media, targeting the amount, level of detail, and content of the information to the needs of the audience. Prepares clear, concise, and well-organized written documents and oral presentations. Conveys information clearly, confidently, and with the proper tone. Facilitates open communication. Uses discretion and demonstrates sensitivity to confidentiality concerns. Listens effectively and provides appropriate feedback.
• Fosters continuous improvement and innovation
• Promotes efforts aimed at improving current business processes through a culture that fosters continuous improvement and innovation. Identifies and implements improvements and innovations that increase efficiency and enhance work quality. Promotes ongoing development of staff and takes initiative to assess and self-develop supervisory competencies.
• Fosters integrity and honesty
• Displays and fosters integrity and honesty through the promotion of mutual trust and respect, demonstrates and fosters high ethical standards, and treats others fairly and ethically.
• Supervises and manages performance
• Builds and manages a multi-sector workforce based on organizational goals, budget considerations, and staffing needs. Ensures staff are recruited and selected using merit principles. Ensures tasks are appropriately delegated and completed by monitoring performance against predetermined standards and requirements and holding staff accountable for meeting expectations. Trains and develops staff, provides constructive performance feedback and appraisals, and takes appropriate corrective action to address performance and conduct issues.
• Manages projects and functions
• Manages projects and leads initiatives in the workplace. Organizes resources, people, and activities; and ensures collaboration and the achievement of project and function goals and targets. Ensures effectiveness and efficiency in the delivery of services, products and/or programs.
• Determines staffing levels; recruits, interviews, selects, hires, and employs appropriate number of employees.
• Provides oversight and direction to the employees in accordance with the organization's policies and procedures.
• Coaches, mentors, and develops staff, including overseeing new employee onboarding and providing career development planning and opportunities.
• Empowers employees to take responsibility for their jobs and goals. Delegates responsibility and holds staff accountable by providing regular feedback.
• Fosters teamwork and cohesiveness among department members; expeditiously initiates conflict resolution when issues arise.
• Creates a workplace culture that is consistent with the mission, vision, guiding principles, and values of the organization.
• Leads employees using a performance management and development processes to include goal setting, feedback, and performance development planning.
• Appropriately communicates organization information through department meetings, one-on-one meetings, appropriate email, and regular interpersonal communication.
• GxP/GDP Training

Working Environment While performing the duties of this job, the employee may occasionally be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens. Other exposures may include gases (nitrogen), or corrosive chemicals (Clorox, potassium hydroxide), or exposure to liquid nitrogen. Must have the ability to work with specialized equipment.The employee must be able to comply with the company's personal hygiene standards as they apply to aseptic processing. The employee must successfully complete sterile gowning training/qualification as well as annual re-qualification as a core competency requirement of their employment in this role. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.