Analytical Instrumentation Manager - QC

  • 51126
  • 11 Nov 2018
  • Grand Island, NY
  • Manufacturing
  • $85,000 - $110,000
  • Scott Heimberg

Job Description

Analytical Instrumentation Manager - QC

POSITION SUMMARY

The Analytical Instrumentation Manager will be responsible for the management of daily activities in support of all analytical equipment in Quality Control. The manager will assure that activities associated with the testing, release and results reporting of materials, products and components meet established and expected quality, Data Integrity requirements, regulatory and customer requirements. The Manager will regularly interact with departments on site and at a corporate level such as Operations, Packaging, Quality Assurance, Stability, Validations and Regulatory Affairs.

PRINCIPAL ACTIVITIES PERFORMED

  • Directs and prioritizes the equipment reliability of multiple laboratories within the QC department to provide for the timely and accurate testing to demonstrate that product meets FDA regulatory quality requirements.
  • Coordinate the training and development of department personnel.
  • Assignment of personnel Goals & Objectives. Perform personnel reviews and administer disciplinary actions as required.
  • Promote a positive work environment for personnel morale and achievement of goals & objectives. Address personnel issues with assistance from Management and Human Resources.
  • Prioritize and track progress of daily activities in functional area for timely release of equipment, for testing of products and components.
  • Perform the role of Subject Matter Expert for the incorporation and maintenance of Data Integrity aspects of all testing laboratories. Act as Administrator for data collection Systems
  • Assure that the integrity of materials, products, components and data is maintained.
  • Assure staff conformance with cGMP and FK USA procedures and policies. =
  • Support investigations and corrective/preventative actions for the Company.
  • Provide technical guidance on existing and improvements to processes, products, procedures and methods.
  • Develop and maintain department budget.
  • Compile information required for Management Reviews and Audit Responses.
  • Represent department at meetings.
  • Provide a work environment for the development of people, the improvement of processes, and the achievement of personal, departmental, and company goals.
  • Provide assistance to the organization within areas of expertise as needed.
  • Provides evaluation and quality control recommendations for new processes relevant to equipment concerns or to troubleshoot existing processes.
  • Stays current with new and changing analytical chemistry requirements, methods, and pharmaceutical changes.
  • Works with peers within the site and/or at other sites to develop and harmonize processes and procedures to improve/enhance the compliance, capability, and capacity

REQUIREMENTS

  • MS with Three years or more related experience, or a BS with five years or more related experience including two or more years as a Supervisor or above.
  • Must possess skills for solving analytical problems.
  • Must have working knowledge of cGMPs, GLP, ICH and USP guidance’s and regulations.
  • Good communication skills and leadership skills are required
  • Strong interpersonal skills and the ability to be highly effective in team settings.
  • Strong project management skills

WHAT CANDIDATES SAY ABOUT THIS RECRUITER:

I would HIGHLY recommend Scott Heimberg. He called me out of the blue, explained the opportunity in detail, gave me guidance for success prior to each phone interview. He set me up for success, unlike previous recruiters. His level of effort and engagement was truly OUTSTANDING!
Gilbert Moore