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Manager, Quality Laboratory Services

Company: Renaissance LLC
Location: Lakewood
Posted on: October 17, 2020

Job Description:

Renaissance LLCAll qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.Overview

The Manager, Quality Laboratory Services provides leadership and management in all areas of the Laboratory Quality systems and the introduction and maintenance of chemical components. Responsible for providing quality oversight over Laboratory Services (QC, AR&D, Spray and Micro) responsible for the testing of raw materials, components, in-process, finished product and stability samples to support both clinical and commercial requirements in a cGMP environment. This includes review and approval of laboratory methods, specifications, procedures, test plans, protocols, and reports. This position is also responsible for managing the Chemical Introduction group, who create and maintain the specifications for new and existing chemical components.

Responsibilities

Technical

--- Provide guidance to direct reports and laboratory personnel in the interpretation of quality issues.
--- Work with R&D and QC organizations to support the successful validation, verification, qualification, and transfer of analytical test methods for release testing.
--- Support drafting of standard operating procedures.
--- Routinely recognize and resolve quality issues. Seek management guidance on complex issues.
--- Assist Quality and Laboratory Services management in the development, implementation, and revision of the Laboratory Quality System.
--- Collaborate with the Laboratory Director and Manager to ensure that quality assurance standards and procedures are in place to meet or exceed those necessary to maintain cGMP compliance.
--- Manage the monitoring of Laboratory practices to verify compliance with Quality System policies and procedures.
--- Perform spot-checks in the QC Labs to ensure compliance with written regulations, policies, procedures, and global procedures.
--- Schedule and coordinate formal quality laboratory audits.
--- Manage quality audits of the Laboratory Services laboratories to verify adherence to the established Laboratory Quality System procedures.
--- Review and approve laboratory Qualification protocols and reports.
--- Calibration records and logbooks of instruments and keep maintenance records including the refrigeration logs, pipette checks, and balance checks.
--- Review and approve Chemical Introduction Change Controls to ensure that appropriate quality standards are implemented.
People Management

--- Provide management and oversight of the daily activities of the Chemical Introduction and Quality Laboratory Services.
--- Participate in the recruitment and selection of employees for the QA Group.
--- Plan and schedule work for the group to ensure proper distribution of assignments.
--- Plan and conduct meetings with subordinates to ensure compliance with established practices, to implement new policies and to keep employees abreast of current changes and standards.
--- Monitor employee performance and provide appropriate and timely recognition of their contributions.
--- Ensure adequate training and development opportunities for QLS employees.
--- Assist employees in setting career goals and managing career expectations.
--- Provide guidance as requested regarding hiring, training, promotions, and disciplinary issues for technical personnel.
--- Understand and comply with all Renaissance safety, environmental and quality practices and procedures as outlined in organizational/departmental guidelines and SOPs as well as applicable federal, state and local regulations.

Qualifications

Bachelor's degree required. Master's degree preferred. A minimum of 10 years of relevant experience in the pharmaceutical industry and 5 years at the supervisory level. Familiarity with analytical and microbiological laboratory operations and systems is required. PI124164668

Keywords: Renaissance LLC, Lakewood , Manager, Quality Laboratory Services, Executive , Lakewood, New Jersey

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