Pfizer QA Floor Inspector 3 in Brentwood, Missouri

ROLE SUMMARY

A third level position with previous training and knowledge in cGMPs relevant to the pharmaceutical industry an aseptic processing. The incumbent will be able to audit aseptic processes for conformance to established specifications, procedures, cGMPs, FDA regulations and identify any non-conformances. The position requires excellent written an oral communication and the ability to work effectively across multiple departments to achieve initiatives. The incumbent must be able to work well with personnel at all levels throughout the organization including peers, operations personnel, supervisors and managers. This role requires the ability to perform job related tasks at a high level independent of direct supervision.

ROLE RESPONSIBILITIES

The essential functions of the position may include, but are not limited to:

  • Communicate non-conformances found during aseptic processing operations to the QA Manager / Supervisor on shift.

  • Follow established procedures and identify gaps as written, update procedures as needed.

  • Ensure adequate coverage for APA and Grade D/CNC areas throughout the shift.

  • Lead monthly In Process Batch Record Review.

  • QA Floor point of contact to QA and Production Management.

  • Train Floor Quality Assurance colleagues

  • In-process review of production batch records for accuracy of documented entries and conformance to established procedures

  • Perform inspection readiness walk-throughs, line clearance, in-process checks and verifications in support of manufacturing activities.

  • Must be able to complete aseptic gowning qualification and work daily in a Grade A/B classified area.

  • Understand and demonstrate aseptic techniques and behavior required in aseptic processing areas

  • Generate daily written shift reports for Quality and Production Management with clear and concise details of relevant issues.

  • Initiate event(s) in QTS per SOP-QLA-MQA-00720, as applicable.

  • Perform PRISM transactions, as applicable.

  • Must be willing to work overtime to support business initiatives. Weekend hours are required.

QUALIFICATIONS

  • High School diploma required; Bachelor's degree in a scientific related discipline is preferred. A combination of relevant education, training and experience will be used to determine candidates with optimal background and in some cases training and experience may be used to suffice educational requirements.

  • PHYSICAL/MENTAL REQUIREMENTS

  • While performing the duties of this job, the employee is occasionally exposed to work near moving mechanical parts.

  • The noise level in the work environment is usually moderate.

  • While performing the duties of this job, the employee is occasionally required to stand; use hands to finger, handle or feel; reach with hands and arms; climb or balance; walk; sit and talk or hear.

  • The employee must occasionally lift and/or move up to 25 pounds. While performing the duties of this job, the employee must don a full body garb suit, hood, mask, goggles, and gloves.

  • The employee will also be required to remain in the full body garb suit, hood, mask, goggles, and gloves for several hours at time.

  • Must have schedule flexibility, depending on the production schedule employees may be required to periodically work overtime, off-shifts (mornings, afternoons, nights or a combination of both), weekends and/or holidays.

  • Position requires regular onsite attendance - this position cannot be performed on a remote or telecommute basis on a temporary, short or long term basis.

  • Must have the ability to simultaneously multi-task across multiple capabilities and functions and handle multiple competing priorities and requirements, including performing site and functional responsibilities, responding to frequent e-mail and phone communications and attending multiple meetings and conference calls. Note that these activities may not be time bound to core hours or presence at the site.

  • Must have the ability to work effectively under and manage to strict production, time and performance deadlines.

  • This is a full time position in the production floor / Aseptic area.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

  • 3rd Shift

  • Aseptic

  • Must be willing to work overtime to support business initiatives.

  • Weekend hours are required.

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.

This job is open only to Lawful Permanent Residents (as defined by 8 U.S.C. §1101(a)(20)), or Protected Individuals (as defined by 8 U.S.C. §1324b(a)(3), namely, U.S. Citizens, 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.

  • Last Date to Apply for Job: 29 September, 2017

  • This job is (Pfizer) (Non-exempt) (US/PR) Grade: 005

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.