Pfizer Compliance Auditor II in United States

ROLE SUMMARY

The Compliance Auditor II is responsible for interpreting the GMP regulations / guidelines and the Pfizer Quality Standards and ensuring that the site remains compliant with these requirements by completing Compliance Analysis Status (CAS) Reports and/or review of CAS Reports completed by Subject Matter Experts (SMEs).

In addition, the Compliance Auditor II is responsible for the quality oversight of the Pest Control program. Compliance Auditor II will contribute to the continuous improvement of the internal processes and may be asked to participate in Quality related Project teams and/or Internal Audits.

ROLE RESPONSIBILITIES

Primary responsibilities include:

  • Pfizer Quality Standard Site Point-Of-Contact (SPOC):

  • Act as point-of-contact for Center PQS Team, for draft and effective PQSs

  • Maintain list of PQS SME gaps assignments for site

  • Distribute draft and effective PQSs to site SMEs for review and/or completion of gap assessments

  • Completes PQS gap assessments within defined timeframe.

  • Reviews PQS gaps assessments performed by others for completeness against PQS process standards

  • Schedule and meet with QO Senior Leadership and SMEs to discuss identified gaps prior to approval

  • Load completed gap assessments to Center PQS SharePoint site by established due dates.

  • Communicates PQS System Document revision schedule and PQS System Document process updates to site.

  • Quality oversight Pest Control Program to ensure is executed as per approved procedures, Pest trends reports are issued and approved, identify trend and follow up actions plans to completion

  • Remain up-to-date on current Regulatory trends (Regulatory Observations, New Regulations/Guidelines) as well as Pfizer Quality Standards.

Additional responsibilities may include, but are not limited to:

  • Performance on Internal Audits

  • Follow up of action items generated from internal Audit & Walkthrough audits.

  • Perform site specific supplier audits as needed.

  • Perform internal audit, write audit reports, and follow-up on audit responses and corrective actions.

  • Other duties within the quality department as required.

QUALIFICATIONS

  • Bachelor's degree in a technical field i.e. Biology, Chemistry, Engineering, Pharmacy and a minimum of five years related experience or equivalent combination of education and experience.

  • Minimum five years of experience in a pharmaceutical production, medical device, and/or combination product environment.

  • Knowledge of Quality Systems in pharmaceutical, medical device, or combination product industry

  • Experienced in auditing with GMP regulated industries is preferred.

  • ASQ Certified Quality Auditor or other equivalent certification is preferred.

  • Experience in aseptic manufacturing is preferable.

  • Fluent in English both speaking & writing

  • Good knowledge of MS Office suite of products

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; 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; sometimes exposed to loud noise.

  • 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.

  • 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.

  • Strong interpersonal and persuasion skills

  • Proven ability to interact effectively with all levels of the organization

  • 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.

  • Excellent communication skills

  • Innovative mind-set: Willing to embrace change and find solutions

  • Take personal accountability for own work, pushing self and others to exceed goals and deliver results.

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

  • Can be counted on to exceed goals successfully; is constantly and consistently one of the top performers; very bottom-line oriented; steadfastly pushes self and others for results.

  • 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

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.

  • Last Date to Apply for Job: May 25, 2018

  • Eligible for Relocation Package

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