Manager, Quality Control, Microbiology - Night Shift

Job Description

Job Description

Salary : Overview

The Manager, Quality Control (QC) Microbiology, is responsible for oversight of day-to-day microbial QC operations at Cell Therapy Center (iCTC). The role will be responsible for working in a GMP- regulated environment and have good understanding of QC microbiology test methods and environmental monitoring. This role must be able to apply phase appropriate cGMPs and regulatory requirements in the product development life cycle, including but not limited to : lot release and stability testing, method qualification and validation, method technology transfers, and writing / review of QC procedures.

Shift : Monday to Friday from 11 : 00pm to 7 : 30am

Essential Functions and Responsibilities

• Manage several analysts at the iCTC in the day-to-day cGMP QC testing of drug products for lot release and stability; Manage microbial testing at contract laboratories
• Manage the technical transfer, qualification, and validation of microbiology test methods for in- process materials, lot release, and / or stability, as needed
• Manage the environmental monitoring program for the facility
• Author, review, and approve SOPs, protocols, reports, specifications, and other quality control documents.
• Ensure trend analysis and trend reports for environmental monitoring data are performed timely.
• Lead investigations for out-of-specification test results, corrective actions, and verification of effectiveness.
• Support product stability programs including generation of stability protocols, execution of stability testing, stability data analysis, and final reporting of stability data.
• Support of site contamination control programs.
• Oversee the maintenance and built of a microbial identification database for all in-house isolates recovered from the various monitoring programs.
• Ensure trend analysis and trend reports for environmental monitoring data are performed timely.
• Support site qualification / validation / commissioning activities, as needed.
• Serve as a qualified trainer, as needed.
• Support career development of microbiology team members.
• Establish positive working relationships with internal and external partners, and implement processes for performance management, including routine meetings, onsite visits, performance monitoring, and issue notification
• Support problem solving for technical issues pertaining to GMP quality control, working alongside technical SMEs as needed
• Operate at a consistent and exemplary level of efficiency, producing high quality and accurate results, in a fast-paced environment
• All duties are performed with minimal supervision and oversight

Required Education, Skills, and Knowledge

Preferred Education, Skills, and Knowledge

The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made upon request to enable individuals to perform essential functions.

Physical Demands and Activities Required :

i.e. scrubs, gowning coverall, masks, gloves, etc.

Mental :

Work Environment :

The statements contained in this document are intended to describe the general nature and level of work being performed by a colleague assigned to this description. They are not intended to constitute a comprehensive list of functions, duties, or local variances. Management retains the discretion to add or to change the duties of the position at any time.

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