Quality Lead, Lab Operations Job at Dendreon Corporation
Overview:
Job Requirements:
Working Conditions and Physical Requirements:
The Quality Lead, Lab Operations is responsible for supporting the department in all areas related to management of laboratory equipment, instrument systems, and general oversight of laboratory operations. This individual will demonstrate proficiency in all relevant testing, laboratory systems, data integrity, and equipment validation and maintenance. Leading by example and display of professional maturity is essential, as well as continuous support of management through initiative, drive, and minimal supervision. Responsible for all higher functions of the laboratory.
Responsibilities:
- Perform in process testing, finished product testing and stability tests for Dendreon products.
- Receive and maintain test samples, reagents and reference standards used in the laboratory per approved procedures, when required
- Represent the Bioassay department as a Subject Matter Expert (SME) to support inspection readiness activities related to routine regulatory inspections, internal, and corporate audit in relation to the laboratory systems & system audits, controlling the management of user accounts, data integrity, traceability and support as required.
- Implement Inspection readiness continuous improvement tasks
- Contributes to the development of long-range plans and needs of the Bioassay function to support new or future laboratory system initiatives.
- Identify quality issues, and effectively and proactively communicate and resolve these in a diplomatic, flexible, and constructive manner.
- Participates and/or lead root cause analysis, Failure Mode and Effect Analyses, NC investigations, LIR Investigations and CAPA effectiveness checks, as required.
- Owns and updates required Standard Operating Procedure (SOP) for applicable revisions, change controls and CAPA as assigned
- Work cross-functionally and cross- site to initiate and own quality change controls, to support the validation and support activities for laboratory equipment
- Prepares quarterly and annual trend reports as related to laboratory systems
- Generates and reports metric data (QRI, Quality Council Monthly), as needed
- System Administrator for and acting Subject Matter Expert (SME) for laboratory related software, such as but not limited to: (ie, Lonza WinkQCL, BC MxP, BC Cytexpert, Chemometec Nucleoview, Freezerworks)
- Perform routine equipment maintenance on laboratory equipment such as but not limited to (Beckman Coulter Cytoflex, Chemometec NC-200 Automated Cell Counter, Lonza ELx808IULON Plate Readers, Biotek ELx-50 Strip Washer, ThermoFisher Sci iEMS Incubator Shaker HT, Rainin LTS Pipettes)
- Act as a project lead for items involving QC instrumentation and systems, such as but not limited to: new laboratory systems or laboratory system upgrades as well as the decommission of obsoleted laboratory systems and instruments.
- Manage QC equipment maintenance and repairs with vendors on: service contracts, requisitions,
- Collaborate with interdepartmental leaders to support, manage, track and complete Laboratory maintenance work orders
- Validation testing to support implementation of new instruments and systems or upgrades in system software.
- Adhere to good documentation practices to ensure data integrity and traceability.
- Perform basic troubleshooting of instrument systems to assist with identifying issues and implementing proper corrective actions to minimize the downtime of instruments and to ensure timely patient testing is not impacted.
- Provide written reports of this activity.
- Creation, revision, and updates of standard operating procedures, test methods, and forms.
- Perform Quarterly trend analysis and maintain other metrics as required.
- Participates in committees or initiatives outside of the Bioassay Department
- Provides training, mentoring, and technical guidance to less experienced QA personnel
- Performs additional tasks as directed by management.
Education Requirements:
Bachelor’s degree in a scientific discipline or equivalent
Job Requirements:
Minimum of 2 years related experience in cGMP/FDA regulated industry- Knowledge of cGMP/ICH/FDA regulations preferred
- Experience with laboratory computerized systems
- Advance level of analysis skills required to evaluate and interpret data to arrive at logical conclusions.
- Understanding on how to apply, and/or experience with, problem solving tools (i.e. Fishbone diagram, IS/IS NOT, DMAIC, Kepnoe/Trego concept, 5Ms and 5 Whys)
- Knowledge of cGMP/QSR/ICH and FDA device/drug/biologics regulations.
- Strong knowledge of assay techniques and principles of product release tests.
- Ability to prioritize and successfully manage complex and competing projects.
- High attention to detail, quality and compliance.
- Strong leadership and communication skills.
- Proficient in MS Word, Excel, Outlook and Project
- Strong oral and written communication skills
Working Conditions and Physical Requirements:
Ability to sit or stand for extended periods of time- Intermittent walking to gain access to work areas
- Finger dexterity sufficient to use a computer and to complete paperwork activities
- Vision sufficient to use a computer, to read written materials and to complete paperwork activities;
- Hearing sufficient to communicate with individuals by telephone and in person
- Ability to lift up to 25 pounds. Limited exposure to (2ºC - 8ºC); (-20ºC); (-75ºC); (-196ºC) areas.
- Must have the ability to work around laboratories, manufacturing areas and equipment, and regularly lift 10 – 20 lbs and lift up to 50 lbs.
- May be required to work alternate shifts
- Ability to gown aseptically for work in Clean Room environments
- Job performed in a lab, office, or utility (noisy) environment
- Must have the ability to work around laboratories, manufacturing areas and equipment with exposure to blood, blood products or OPIM (other potentially infectious materials) while donning required personal protective materials.
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