Stability Program Manager in Cary, IL at Stryker Corporation

Date Posted: 9/25/2018

Job Snapshot

Job Description

Essential Duties & Responsibilities:

  • Serve as the central point of contact for all product stability program activities in the site
  • Coordinate all stability program activities in the site
  • Develop and maintain a detailed understanding of all government regulations regarding all aspects of stability testing
  • Develop and maintain a detailed understanding of all corporate policies and procedures regarding stability testing
  • Aid in regulatory audits on all matters relating to product stability
  • Draft and maintain stability program policies and procedures as necessary to maintain compliance
  • Help establish and monitor stability related Quality Assurance programs and procedures to ensure compliance
  • Advise management on any corrective action required to maintain regulatory compliance with stability regulations and guidelines
  • Ensure the performance of periodic review of stability program
  • Develop goals for direct reports and provide training

Education & Special Training:

  • B.S./ B.A. in chemistry or a related technical field is required, an advanced degree is preferred.
  • In-depth knowledge in a broad range of analytical instrumentation is required
  • In-depth knowledge in pharmaceutical stability testing is required

Qualifications & Experience:

  • 8+ Years’ relevant experience with B.S./B.A.
  • 4+ Years’ relevant experience with M.S.
  • Proven experience in quality management and improvement
  • In depth understanding of quality control stability procedures and relevant legal standards
  • Excellent math abilities and working knowledge of data analysis/statistical methods
  • Excellent organizational and leadership skills
  • 5 to 10 years’ business experience working with Pharmaceutical Quality Control/Quality Assurance

Work From Home: No

Travel Percentage: Up to 25%

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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