Night Shift Senior Quality Operations Professional

Pfizer Mcpherson , KS 67460

Posted 1 week ago

ROLE SUMMARY

This posting is for a position on the Quality Assurance on the Floor team supporting deviations and providing real time quality impact support (including off shift and weekends) in McPherson Drug Product Operations. 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

  • Independently provide Real Time Quality impact assessments and decisions (24/7) on Drug Product issues as needed:

  • Ability to handle complex and detailed situations

  • Accurately assess consequences of decisions

  • Accurately assess potential Regulatory impacts on a Global basis

  • Immediately escalate issues with potential market or stability impact

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

  • Participates in QAR Gembas with customers and peers

  • After initial assessment of QARs and ERs, successfully transitions remainder of investigation to others to complete investigation write up as needed

  • Effectively leads/facilitates/participates/completes cross-functional team investigations for FARs and Significant Deviations and when applicable aids in drafting of AQRT summary

  • Utilize tools such as Method 1 and Pfizer Human Performance in the course of the investigations

  • Participate in QRM assessments that gain approval through Site and Area QO Management

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

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

  • Independently assess a wide range of Change Control activities to determine potential Quality and Operational GMP impacts

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

  • Participates in internal GMP audits

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

  • Actively demonstrate Pfizer leader behaviors.

  • Mentor/Train entry level QOPs

  • Answer questions on all aspects of the Triage / Floor Support workload

Develop/Train other QOPs.

QUALIFICATIONS

Education: Preferred BS in Chemistry, Biochemistry, Microbiology, Engineering or other science related discipline.

Experience: Minimum 4 years pharmaceutical experience. Preferred 2+ years experience writing and managing deviations. Quality Assurance experience required.

Soft Skills:
Strong Leader Behaviors willing to lead by example and jump right in, Demonstrated desire to understand how things work and get to true root cause, Strong sense of ownership, Collaborative/Active Listener, Effectively manages stressful situations able to focus on task at hand and focus others regardless of circumstances and stress induced pressure

Other Skills:
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.

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.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

This position requires weekends and off shift and some day shift as business needs dictate. Successful candidate will be required to complete various levels of gowning certification in order to enter and support the manufacturing areas.

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.

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.

  • Last Date to Apply for Job: April 24, 2019

Eligible for Relocation Package: Yes


Eligible for Employee Referral

Bonus:
Yes

N (Other) (United States of America)

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


icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Night Shift Manager Quality Operations Professional

Pfizer

Posted 1 week ago

VIEW JOBS 4/12/2019 12:00:00 AM 2019-07-11T00:00 ROLE SUMMARY This posting is for a position on the Quality Assurance on the Floor team supporting deviations and providing real time quality impact support (including off shift and weekends) in McPherson Drug Product Operations. 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 * Independently provide Real Time Quality impact assessments and decisions (24/7) on all Drug Product Issues as needed * Ability to handle complex and detailed situations * Accurately assess consequences of decisions * Accurately assess potential Regulatory impacts on a Global basis * Immediately escalate issues with potential market or stability impact * Accurately communicate Supply/Operational needs/perspectives as well as QO perspectives. * Participates in and leads QAR Gembas with customers and peers * After initial assessment of QARs and ERs, successfully transitions remainder of investigation to others to complete investigation write up * Effectively leads/facilitates/participates/completes cross-functional team investigations for FARs and Significant Deviations and when applicable aids in drafting of AQRT summary * Utilize tools such as Method 1, Human Error Reduction (HER), & Solution Tree in the course of the investigations * Participate in QRM assessments that gain approval through Site and Area QO Management * Participate in Green/Black belt projects, RFT% Improvement projects, CAPA Effectiveness, etc… as appropriate * Propose and implement improvements in the Deviation and/or Floor Support operations * Independently assess a wide range of Change Control activities (PTVAs, Protocol development, SOP and MBR changes) to determine potential Quality and Operational GMP impacts * SME support during Regulatory/Customer audits including contributions to strategies to successfully respond to auditor concerns * Participates in internal GMP audits * Ability to represent DP QA Team Leaders/Managers when needed, including ability to approve deviations as QA Managers * Effectively communicate complex technical issues to all levels of Management (including outside of Quality) * Be able to mentor QOPs at level 4 and/or 7 * Answer questions on all aspects of the Triage / Floor Support workload Develop/Train other QOPs. QUALIFICATIONS Education: BS in Chemistry, Biochemistry, Microbiology, Engineering or other science related discipline. Experience: Minimum 10 years pharmaceutical experience. Preferred 2+ years experience writing and managing deviations. Quality Assurance experience required. Soft Skills: Strong Leader Behaviors – willing to lead by example and jump right in, Demonstrated desire to understand how things work and get to true root cause, Strong sense of ownership, Collaborative/Active Listener, Effectively manages stressful situations – able to focus on task at hand and focus others regardless of circumstances and stress induced pressure Other Skills: 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. Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact. 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. NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS This position requires weekend and off shift and some day shift as business needs dictate. Successful candidate will be required to complete various levels of gowning certification in order to enter and support the manufacturing areas. 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. * Last Date to Apply for Job: April 24, 2019 Eligible for Relocation Package (REQUIRED IF BEING OFFERED) Eligible for Employee Referral Bonus (REQUIRED IF BEING OFFERED) 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. N (Other) (United States of America) Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates. Pfizer Mcpherson KS

Night Shift Senior Quality Operations Professional

Pfizer