QC Laboratory Manager in Cary, IL at Stryker Corporation

Date Posted: 11/17/2019

Job Snapshot

Job Description

Who we want:

Compliance-focused orchestrators. Managers who carefully oversee people, processes, and deliverables to ensure compliance with company policies and procedures

Metrics-oriented managers. People who are always tracking important business metrics to ensure projects meet expectations and budget

Quality-focused team drivers. People who push their team to deliver the highest quality products and solutions in a timely manner.

Subject matter experts. Managers who not only oversee the collection, review, and analysis of data but can interpret, translate, and present on all various matters as needed.

What you will do:

As a QC Laboratory Manager, you will develop and oversee the Quality Control chemistry program to ensure products are tested in compliance with applicable US Federal and International regulations. Provide support to Production & Registration Depts. on international (e.g., Canada, Europe) QC, Stability, and other related regulatory standards. Assist Management in responding to FDA and other regulatory agencies on technical issues. Ensure that QC personnel interact effectively with the Quality Assurance Unit, Manufacturing personnel, and Engineering personnel. Provide training and development to assure group personnel are adequately skilled to perform assigned functions and that the group operates in an orderly and efficient manner.

Essential Duties & Responsibilities

  • Develop, validate and approve methods
  • Plan and direct projects
  • Evaluate and specify instrument purchases
  • Design, implement, approve and assign operational procedures
  • Develop and direct execution of protocols
  • Review and approve data
  • Write and review reports
  • Trainer for advanced techniques, methods and theory
  • Represent QC Lab in audits
  • Prepare department forecasts
  • Internal and External customer interface
  • Overall responsibility for the site stability testing program
  • Present and publish papers
  • Ensure compliance to relevant GMP/GDP And Quality Systems standards
  • Prepare and present reports of departmental measure of appropriate quality to internal management.
  • Establish and maintain documented processes to ensure that product disposition and release of compliant product are performed within agreed lead-times.
  • Review the implementation and efficiency of quality and inspection systems

What you need:

Basic Qualifications:

  • B.S./ B.A. in Chemistry or a related technical field is required.
  • 5+ Years’ experience in analytical chemistry, working in a laboratory environment, pharmaceuticals or relevant experience with B.S./B.A.
  • 3+ Years’ experience in analytical chemistry, working in a laboratory environment, pharmaceuticals or relevant experience with M.S.
  • 2+ Years’ experience in analytical chemistry, working in a laboratory environment, pharmaceuticals or relevant experience with Ph.D.
  • 1 year supervisory/management experience required.

Preferred Qualifications:

  • Proven experience in quality management and improvement.
  • In depth understanding of quality control procedures and relevant legal standards.
  • Excellent math abilities and working knowledge of data analysis/statistical methods.
  • Experience with Continuous Improvement tools and applications.
  • Excellent organizational and leadership skills.
  • Experience in Quality Risk Management.
  • Experience working with manufacturing facilities/processes.
  • Experience with quantitative and qualitative chemical analysis and demonstrated proficiency with major analytical techniques such as Chromatography (GC, HPLC) and Spectroscopy (FTIR, UV/Vis).
  • Experience in an FDA GMP (Good Manufacturing Practice) compliant laboratory.
  • Experience with a Laboratory Information Management System (LIMS) is a plus.
  • Experience conducting shelf-life and related stability studies is a plus.

Work From Home: Not available

Travel Percentage: None

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.

Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.

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