Manager, Quality Laboratory Services
Company: Renaissance LLC
Posted on: October 17, 2020
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.
--- 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
--- 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
--- Schedule and coordinate formal quality laboratory audits.
--- Manage quality audits of the Laboratory Services laboratories
to verify adherence to the established Laboratory Quality System
--- Review and approve laboratory Qualification protocols and
--- 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.
--- 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
--- Assist employees in setting career goals and managing career
--- 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.
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.
Keywords: Renaissance LLC, Lakewood , Manager, Quality Laboratory Services, Executive , Lakewood, New Jersey
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