Sr. Quality Operations Specialist - Internal Audits

Employer
Pfizer
Location
St. Louis, Missouri
Posted
Oct 01, 2021
Ref
4815999
Required Education
Bachelors Degree
Position Type
Full time
Why Patients Need You

Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients.  Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.

Role Summary

This position is responsible for interpreting the GMP regulations / guidelines and the Pfizer Quality Standards and ensuring that the site remains compliant with these requirements. Sr. Quality Operations Specialist – Internal Audits (Sr. QOS – Internal Audits) will ensure realization of the site self-assessment program (SSA)/ Internal Audit program by conducting internal audits/ walkthroughs, ensuring the follow-up on corrective/preventive actions, and assisting with Inspection Readiness.

Sr. QOS – Internal Audits will report findings in a clear, precise and factual way. Responsible for suggesting and evaluating changes to the site’s quality system. Work closely with all GMP departments to improve overall company’s quality and make sure that site personnel are properly trained / qualified to perform their assigned duties. Sr. QOS – Internal Audits will contribute to the continuous improvement of the internal processes and may be asked to participate in Quality related Project teams.

How You Will Achieve It
  • Perform internal audit/walkthrough, write reports, and follow-up on responses and corrective/preventive actions.
  • Remain up-to-date on current Regulatory trends (Regulatory Observations, New Regulations/Guidelines) as well as Pfizer Quality Standards.
  • Assist departments with improvement projects as they relate to inspection readiness and as identified during Site Self Assessments and walkthroughs
  • Support and prepare site for audits and regulatory inspections.
  • Facilitate other internal and external audits/assessments/surveys.
  • Perform other Quality Compliance functions as needed.

QualificationsMust-Have
  • Bachelor's Degree
  • 3+ years' experience
  • Knowledge of U.S. FDA, ICH, and PIC/S and other international regulations for pharmaceutical and/or medical device. 
  • ASQ Certified Quality Auditor (or other 3rd party auditor certification) required
  • Experienced in auditing with pharmaceutical/medical device GMP regulated industries required
  • Good technical writing skills, and communication as well as presentation skills
Nice-to-Have
  • Experience in an aseptic manufacturing facility
  • Experience with preparation and/or facilitation of regulatory inspections (U.S. FDA, EMA, etc.) is preferable.
  • Strong knowledge and understanding of ISO 13485, ISO 14971, and 21 CFR 820

  

Physical Requirements

While performing the duties of this job, the employee is occasionally required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms and talk or hear; ability to lift up to 25 lbs.; the noise level in the work environment is usually moderate but may be exposed to loud noise. Specific vision abilities include ability to adjust focus and distinguish colors.

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

Mental Requirements

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.

Work independently, with minimal supervision, and in a team environment under strict time guidelines; Stress (system owners/users expect immediate attention to and resolution of problems); Flexibility/organizational skills; speed and dexterity required.

Team player: Is easy to approach and talk to; spends the extra effort to put others at ease; can be warm, pleasant, and gracious; is sensitive to and patient with the interpersonal anxieties of others; builds rapport well; is a good listener; is an early knower, getting informal and incomplete information in time to do something about it.

 

Makes good decisions in a timely manner based on analysis, experience, and judgment, even with incomplete information or under time pressure.

 

Accurately scopes out length and difficulty of tasks and projects; sets objectives and goals; breaks down work into the process steps; develops schedules and task/people assignments; anticipates and adjusts for problems and roadblocks; measures performance against goals; evaluates results.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

•  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 work effectively under and manage to strict production, time and performance deadlines.

•  Travel between Westport and Brentwood sites required

•  Travel to Maryland location required on a limited basis

•  Position may require working non-standard hours and days to ensure continuity of the Internal Audit program and Quality Compliance.

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

Last date to apply for job: October 15 , 2021

Eligible for Relocation Support

Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment.  As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.

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.

Quality Assurance and Control