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Quality Control Chemistry Manager

Website AB BioTechnologies, Inc.

 

Position Summary

Plans, organizes and directs the essential functions of quality control chemistry activities in support of the production of injectable drug products.

Essential Responsibilities and Duties

  • Optimizes efficiency of the working environment of the group
  • Ensures training of the group is complete
  • Develops, implements, maintains and performs quality control activities including analysis, instrument qualification/preventive maintenance, method validation, and training
  • Schedules and coordinates the routine and non-routine analysis of raw materials, in-process, and finished products according to standard operating procedures
  • Schedules and coordinates the routine and non-routine analysis of raw materials, in-
  • Provides hands on leadership to troubleshoot analytical instrumentation
  • Prepares, performs, leads and/or manages QC audits, (e.g.: instrument logs, standard logs, and out of specification results)
  • Ensures adherence to SOPs, FDA guidelines and other regulatory requirements
  • Makes project/work assignments with communication of the expected timeline
  • Monitors the progress against the timelines
  • Provides troubleshooting support as needed
  • Effectively communicates with clients and internal groups
  • Evaluates personnel in a timely manner
  • Works effectively with Project Management and Production personnel
  • Oversight of all quality investigations to ensure timely closure
  • Ensures all laboratory equipment that is used to measure the product quality is maintained and calibrated
  • Attend leadership meetings to represent the quality control chemistry group
  • Ensures data integrity with all reports and tests

Supervisory Responsibilities

  • Position Title Supervised: Quality Control Chemist
    • Approximate Number of Subordinates: 4

Qualifications, Education and/or Experience Requirements

  • BS degree in chemistry or related science with 10+ pharmaceutical laboratory experience with 3+ years in supervision
  • Working knowledge of 21 CFR 210,211
  • Knowledge of laboratory techniques and good laboratory practices
  • Experience with analytical equipment including HPLC, osmolality, density, balances, TOC, Endotoxin (LAL), UV/Vis, pH meter, Karl Fischer
  • Strong analytical skills
  • Strong leadership skills
  • Strong problem solving and investigative skills
  • Ability to multi-task, manage multiple projects at one time, and rapidly change priorities based on business needs
  • Excellent written and verbal communication skills
  • High integrity with respect to maintenance of proprietary and confidential information
  • Composure under pressure
  • Strong problem solving capabilities
  • Excellent organizational and presentation skills.

Working Conditions

While performing the duties of this job, the employee is occasionally required to stand; walk; sit; use hands to finger, handle, or feel objects, tools or controls; reach with hands and arms; climb stairs; balance; stoop, kneel, crouch or crawl; talk or hear; and taste or smell. The employee must occasionally lift or move up to 25 pounds. Specific vision abilities required by the job include close vision, distance vision, color vision, peripheral vision, depth perception and the ability to adjust focus.

Tools, Equipment, and Other Resources Used

This job operates in a professional laboratory environment. In addition to scientific equipment, this role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets, fax machines and various software applications sustained by a Windows platform. (Excel, Word, PowerPoint, etc.)

Performance Demands

Characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

 

 

To apply for this job please visit the following URL: https://www.ab-biotech.com/job/484/ →

Author: Dana Palazzo

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