Pfizer QO Specialist in United States

  • ROLE SUMMARY This posting is for a position on the MQA team supporting deviations and providing real time quality impact support (including off shift and weekends) in Westport Packaging and Inspection Operation. The colleague will need to effectively work/communicate with key stakeholders and peers to ensure timely completion of non-conformance investigations reports with effective corrective/preventative actions (CAPA). ROLE RESPONSIBILITIES

  • Provide real time batch record spot reviews

  • Independently provide real time quality impact assessments and decisions on Drug Product issues as needed:

  • Ability to handle complex and detailed situations

  • Accurately assess consequences of decisions

  • Immediately escalate issues with potential market or stability impact

  • Accurately communicate Supply/Operational needs/perspectives as well as QO perspectives.

  • Propose and implement improvements in the Deviation and/or Floor Support operations

  • Work with Operations to correct and reduce errors through effective communication and continuous improvement initiatives

  • Independently assess a wide range of Change Control activities (Protocol development, SOP and MBR changes) to determine potential Quality and Operational GMP impacts

  • Effectively communicate complex technical issues to all levels of Management (including outside of Quality)

  • SME support during Regulatory/Customer audits including contributions to strategies to successfully respond to auditor concerns

  • Participate in Green/Black belt projects, RFT% Improvement projects, CAPA Effectiveness, etc... as appropriate

  • Actively demonstrate Pfizer leader behaviors.

  • BASIC QUALIFICATIONS Education: BS in Chemistry, Biochemistry, Microbiology, Engineering or other science related disciplineExperience: Minimum 3 years pharmaceutical experience. Experience writing and managing deviations. PREFERRED QUALIFICATIONS

  • Experience writing and managing deviations.

  • PHYSICAL/MENTAL REQUIREMENTS Office position with significant time in the production environment. Independently, with minimal guidance, consistently produces quality work. Must be able to work in a team environment within own team and interdepartmental teams. Must work under short timelines while maintaining quality work. Must have effective written and oral communication skills.

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.

The job is open only to Protected Individuals (as defined by 8 U.S.C. ยง 1324b(a)(3), namely, Citizens or Nationals of the United States, Lawful Permanent Residents ("green card holders"), Refugees and Asylees.

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.

Other Job Details:

  • Last Date to Apply for Job: 26 July, 2018

  • Eligible for Relocation Package - Yes

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