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Quality Control Team Leader United States,  

Lilly (company)


Posted on : 27 August 2017

Project Description

34948
Quality Control Team Leader
Winslow
Maine
United States
Local
Elanco is a global research-based company that develops and delivers product and services to enhance animal health and production. We value innovation, both in scientific research and daily operations, and strive to cultivate a collaborative work environment for more than 7,000 employees worldwide. Founded in 1954, Elanco is a division of Lilly. Our worldwide headquarters and research facilities are in Greenfield, Indiana.
Manage activities of the Quality Control and Avian Services Departments including, but not limited to: compiling, reviewing and submitting to Quality Assurance all USDA paperwork to support release of licensed products; train, coordinate, and monitor the activities of analysts and technicians; provide technical support for analysts and technicians; provide technical assistance personally and through subordinates to the implementation and completion of development projects; coordinate the testing of product and the prompt reporting of test data to affected departments; implement and enforce SOPs and company policies to ensure compliance with 9 CFR regulations; implementation of new testing techniques within USDA guidelines to improve the testing quality and timeliness of results; promote and build team concepts and efforts both within the department and company.

Functions, Duties, Tasks:

  • Collects, reviews, interprets, compiles, and submits all test results and USDA documentation concerning product or serial release to Quality Assurance.
  • Coordinate with Avian Services personnel to ensure that the transfer of products or materials for testing is done in a timely and efficient manner.
  • Notify appropriate persons and functions (Prod., TS/MS, SC) of any potential or failed test results or product quality problems encountered.
  • Maintains master, working, production, and challenge seed stocks and related documentation.
  • Oversees the stock of testing reagents. Coordinates the production and testing of new lots of reagents as required.
  • Leads, trains, monitors, and evaluates the performance and behavior of QC and AS personnel and coordinates their work activities; Reviews and manages employee training plans, ensuring employees are competent to perform duties.
  • Responsible for trouble shooting technical problems and providing scientific backup for the analysts and technicians. Assists with testing when necessary.
  • Provides assistance with projects and initiatives as a member of project teams with regard to laboratory testing.
  • Communicates product quality problems, recommends corrective action (s), and specifies follow-up procedures.
  • Develops and initiates investigations to improve the quality, efficiency, or safety of in vitro and in vivo related techniques or procedures.
  • Develops, reviews and routinely updates SOP s.
  • Provides weekly reports of technical information via the central QC/AS reporting system.
  • Provides initial and weekly updates of projected final product and antigen release dates.
  • Prepares and submits annual operating and capital improvement budget requests to meet demand.
  • Leads, trains, monitors, coordinates and evaluates the performance and competency of QC and AS personnel.
  • Manages staff schedules to achieve maximum efficiency and utilization of the Company s resources; Reviews and approves employee time cards for payroll in accordance with Personnel Policies.
  • Provides monthly testing metrics for site Quality Lead Team and Global network metric review meetings

34948BR
  • Bachelor s degree in the biological or related sciences
  • Five years Quality Control or related laboratory experience including SOP s and GMP s, experience in the compliance to governmental regulations (USDA and/or FDA).
  • 1 year experience in managing personnel, team leadership, and overall quality education and assessment is required.
  • Must be able to obtain and maintain FBI Select Agent Clearance
  • Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.
  • Must possess advanced oral and written communication skills.
  • Experience or knowledge of Regulatory duties
  • Time management, flexibility and the ability to multitask
  • Proficient in Microsoft Office, including Word, Excel and Power Point
  • > 10% travel may be required
  • Personal Protective Equipment may be required when working in certain areas
  • Biosecurity environment within a manufacturing site
Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

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Locations

Maine, United States

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