Overview
Lab Technician – Quality – 12 Hour Shifts, Days Jobs in Newark, DE at LaMotte Chemical Products Company
Annual Salary- $70,000-$80,000
Essential Job Responsibilities and Duties
Responsible for the personnel functions of one or more Center’s Quality Team; including direction, assignment of work, hiring, development, training, disciplinary actions, termination, maintenance of personnel records, work schedules, and delegation of tasks
Ensure compliance with training needs, SOPs, processes and other regulatory or company directives are adhered to support the operations and quality requirements for business operations
Facilitate onboarding and training for new Quality Team Members at one or more Center
Ensures compliance with training records and materials are maintained, consistent, in accordance with regulations and ImmunoTek Standard Operating Procedures
Complete all Quality Tasks in the absence of a Center’s Quality Team Members
Oversight of all aspects of internal and external audits including documentation, review preparation of the responses, implementation of corrective and preventative action, effectiveness checks of CAPA’s, ensured guidelines are met and follow-up as required
Audit host for local centers
Facilitate and evaluate equipment readiness
Verify and manage product, sample, and waste shipments
Receive, approve and release donor center supplies
Works in collaboration with Center Management to develop the staff’s knowledge of their job function and to ensure training is conducted and completed according to ImmunoTek’ s Training Program
Oversee and manage one or more Center’s Deviation Management System to ensure adequate investigations are completed, accurate root cause(s) identified, and CAPA process is identified and managed
Documents and tracks one or more Center’s quality and operational metrics with respect to applicable SOPs and follow-up on incidents/errors as required; reports critical incidents and problematic trends to center management
Perform periodic self-assessments of one or more Center’s quality and compliance
Administratively oversee the performance and submission of a center’s Proficiency Testing process (Note: this does not replace any CLIA regulated process)
Interprets and Implements processes, and SOPs for quality control and overall regulatory compliance, making independent decisions and modifications as required
Promote Safety, Health and Environment Policies & Procedures. Ensure safety training and safety practices are implemented and followed within a center
Receive and provide feedback to staff on observations leading to improved adherence to GMP standards. Coach and develop area personnel regarding concerns or deficiencies. Report area personnel concerns or deficiencies to area management immediately. Make recommendations for remedial actions to resolve audit observations and other non-compliance issues of deficiencies.
Ensure that the centers Quality and Training Program maintain compliance with all state, federal, European regulations in a Current Good Manufacturing Practice (cGMP), environment.
Participate with management to develop programs and methods to streamline center processes resulting in improved customer/donor service, product yields and financial results while maintaining compliance and quality.
Create an appropriate organizational environment and value system which stimulates the morale and productivity of the work force and its leadership
Adhere to all HR policies and practices through fair and equitable treatment of all employees.
Learn and maintain thorough familiarity and compliance with all state and federal regulations, Standard Operating Procedure Manual, Occupational Safety and Health Administration (OSHA), Clinical Laboratory Improvement Amendments (CLIA), Current Good Manufacturing Practice (cGMP), and internal Company Procedures
Thorough knowledge of applicable Company and departmental policies and procedures as well as the willingness to learn and follow any policy or procedure that may be introduced in the future
Maintain an open line of communication with Management
Ensure and maintain the confidentiality of all personnel, donor, and center information
Maintain a positive and professional demeanor during all interactions with donors, fellow employees, and vendors
Ability to accept performance feedback in a professional manner
Other duties as assigned
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Title: Lab Technician – Quality – 12 Hour Shifts, Days
Company: LaMotte Chemical Products Company
Location: Newark, DE