Pfizer Sr Specialist QO in Kalamazoo, Michigan

ROLE SUMMARY

This posting is for a Sr Specialist QO in the Analytical Services group. The Analytical Services group is responsible for the Kalamazoo site Stability, Retain, and Reference Standard programs. This position will support a combination of these programs and is responsible for ensuring they remain in compliance with both internal and external regulatory requirements through maintenance of area standard operating procedures and training documents, understanding of requirements for handling and storage of controlled substances, and equipment monitoring and periodic reviews. The successful candidate will provide guidance and support to technicians in the area, represent the unit on cross functional project teams, and function as a subject matter expert during audits.

ROLE RESPONSIBILITIES

  • Work with operations schedulers to order stability lots required by SLS stability protocols, provide lot information obtained from SAP, LIMS, and various other sources to SLS stability group to ensure appropriate study creation in LIMS, and ensure samples are transferred to the appropriate storage conditions according to a defined schedule. Ensure samples are pulled and delivered to labs for testing at appropriate intervals.

  • Maintain an appropriate inventory of characterized Reference Standards needed by the Kalamazoo QO Laboratories. Obtain bulk standard material, submit samples to appropriate labs for required testing, author and/or review characterization reports, create certificates of analysis, manage inventory in LIMS stock management module, and fulfill laboratory orders as needed.

  • Ensure appropriate processing of Retain samples and compliance with annual inspection schedule.

  • Assist team members and customers in investigation and resolution of items outside of the routine workload.

  • Assist customers with special requests or needs.

  • Lead or contribute to special projects.

  • Process revisions to documents and test plans using local change control systems.

  • Participate in system development and design.

  • Interact with individuals at a variety of levels in the following areas: Operations, Quality Operations Laboratories, Quality Assurance, Complaints, SLS Stability.

  • Meet performance metrics for supported programs.

QUALIFICATIONS

  • Bachelors Degree (science or related field is preferred)

  • Minimum of five years related experience

  • Excellent organizational skills and demonstrated ability to meet changing deadlines and deliver results on time

  • Excellent communication skills to support all levels of customers and maintain effective customer relationships

  • Demonstrated agility/performance in a changing environment and have a willingness to be active in continuous improvement initiatives

  • Demonstrated ability to work both independently and in a team environment

  • Demonstrated commitment to values based leadership and achieving objectives in a manner that is supportive of Pfizer Values and Core Competencies

  • Knowledge and use of quality systems (e.g. LIMS, SAP, QTS) is required

  • Ability to comprehend and apply information from guidance documents (e.g. PQS, CFR) to functional processes

  • Familiarity with Stability, Reference Standards, and Retains programs preferred

  • Analytical laboratory experience preferred

PHYSICAL/MENTAL REQUIREMENTS

Ability to lift up to 35 pounds

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Off-hours/on-call support is required on a rotational basis.

EEO & Employment Eligibility

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

SUNSHINE ACT

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

Additional Offer Details:

  • Last Date to Apply for Job:October 19, 2017

  • This job is Pfizer/Exempt (US/PR) Grade: 07

A career at Pfizer offers opportunity, ownership and impact.

All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the bio-pharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.