Stability Supervisor, Quality Laboratory Services
Company: Renaissance LLC
Posted on: November 20, 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 Stability Supervisor, Quality Laboratory Services oversees and
coordinates the daily activities of the Quality Laboratory Services
Stability Group to ensure that technical data and documentation
generated by Stability function is accurate and meets all
established protocol and Client timelines. The Stability Supervisor
interacts with other functional departments to ensure Stability
services are provided timely, efficiently and in compliance with
all Renaissance and cGMP standards.
Carry out supervisory responsibilities in accordance with the
organization's policies and applicable laws. Responsibilities
include interviewing, hiring, and training employees; planning,
assigning, and directing work; appraising performance; rewarding
and disciplining employees; addressing complaints and resolving
--- Perform/oversee Stability DEA inventory.
--- Ensure the accurate and timely input of QC data into the
stability information systems: e.g.: ScienTek or LIMS system.
--- Act as primary point of contact for Stability team members when
problems or issues arise and facilitate resolution of issues.
--- Identify, conduct and lead opportunities to continuously
improve quality, cost and efficiency of processes in accordance
with the strategic direction of the department to fulfill company
and department goals.
--- Actively participate in cross functional teams for problem
solving and continuous improvement.
--- Manage and update stability program SOPs as required.
--- Review and implementation of regulatory requirements for
--- Generation, review, approval, and execution of stability
protocols in LIMS.
--- Proficient in ScienTek, LIMS or equivalent system to create and
initiate stability studies.
--- Prepare documentation of trend analysis reports, and stability
summary reports for regulatory submissions.
--- Proficient in trend analysis using statistical software
--- Ensuring that all chemical and microbiology tests associated
with drug product stability studies is completed per approved
--- Labeling and storage of stability samples.
--- Monitoring the periodic maintenance and calibration of company
--- Direct the work activities of the Stability group to ensure
that stability studies are initiated, pulled, and reported in a
timely and compliant manner.
--- Monitor and coach performance of team members. Conduct annual
--- 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.
--- May interview prospective department 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 in a Natural Science with 5 - 8 years of
experience in stability science or analytical chemistry within the
pharmaceutical industry. Prior stability data statistical trend
analysis experience is preferred. Additional education may be
substituted for experience on a year per year basis.
Keywords: Renaissance LLC, Lakewood , Stability Supervisor, Quality Laboratory Services, Healthcare , Lakewood, New Jersey
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