Sr Quality Operations Specialist/Quality Operations Manager
Pfizer Inc. - Kalamazoo, MI

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Pfizer Inc: Working together for a healthier world

Founded in 1849, Pfizer is the world's premier biopharmaceutical company taking new approaches to better health. We discover, develop, manufacture and deliver quality, safe and effective prescription medicines to treat and help prevent disease for both people and animals. We also partner with healthcare providers, governments and local communities around the world to expand access to our medicines and to provide better quality health care and health system support. At Pfizer, colleagues in more than 90 countries work every day to help people stay happier and healthier longer and to reduce the human and economic burden of disease worldwide.

At Pfizer, we've long recognized that our colleagues are our most important asset. We value our colleagues, recognize their talent, encourage their growth and reward their performance. It's a terrific environment that enables people to contribute, to do their best, and to achieve their potential.

Throughout our history, a legacy of caring for others has been at the heart of everything we do at Pfizer. This commitment is no less important when it comes to our employees.

When you choose a Pfizer career, we provide the resources to help you develop and succeed both in your career and your personal life. One way we can achieve this is through our comprehensive benefits program, which offers employees and their eligible dependents the variety and flexibility to help address their needs at different stages in life.

This role reports to the Manager/Team Leader for Supplier Quality. This position is for a Supplier Auditor, and has responsibility for the assessment of supplier quality systems and facilities. The role requires the initial completion of a training program required for certification as a qualified auditor for Pfizer, scheduling and execution of supplier audits throughout the United States and occasionally outside them, assignment of an audit rating for each audit performed, authorship of the associated audit reports, planning of any required travel to/from supplier locations, and submission of associated expense reports. As the auditing function requires a high degree of independent operation outside of the Kalamazoo site, it is expected that candidates will be able to demonstrate consistent professionalism and sound judgment, while acting as Pfizer representatives to these suppliers and service providers. In addition, team members will be expected to exhibit a broad-based understanding of quality system requirements and expectations for varying categories of commodities, and to manage time effectively, so that all areas are suitably reviewed during the scheduled audit time. This role also requires significant interaction with Center colleagues in similar roles, and the ability to use existing company and site systems to plan and execute supplier audits.

  • Bachelors Degree with 4+ years of pharmaceutical experience.
  • Strong interpersonal, oral, and written communication skills.
  • Demonstrated success interacting with personnel of varying levels is required.
  • Demonstrated knowledge in a variety of GMP disciplines and a working knowledge of
general Quality Assurance principles.

  • Experience in reviewing and assessing the compliance of quality systems is desired.
  • Demonstrated ability to manage behaviors in a way that is consistent with the externally-
facing nature of the Auditor role.

  • Working knowledge of risk management principles, as well as a demonstrated ability to
apply them to meaningfully differentiate potential sources of risk.

Required technical competencies include:
  • Candidate must have the ability to manage a variety of deadlines.
  • Must be able to work highly independently, as well as within the team to accomplish goals.
  • Strong leadership skills, communication skills (both oral and written).
  • Knowledge of site change control systems.
  • Knowledge of GMP Requirements, Corporate Quality Standards and Guidances, and other
regulatory requirements is necessary.

  • Ability to apply various guidances in a manner that is consistent with the level of GMP
expectation associated with process materials at varying stages of GMP compliance.

  • Must be self-motivated with limited immediate direction, and willing to learn new and
changing responsibilities.

  • Candidate must also possess demonstrated commitment to values-based leadership, and
achieving objectives in a manner that is supportive of Pfizer Values and Leader Behaviors.

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Pfizer pfabricates pfarmaceuticals pfor quite a pfew inpfirmities. The company is the world's largest research-based pharmaceuticals...