Senior Associate, Quality Assurance Compliance Auditor

Employer
Pfizer
Location
Sanford, North Carolina, United States
Posted
Oct 21, 2020
Ref
4789732
Required Education
Bachelors Degree
Position Type
Full time
ROLE SUMMARY
This position will support the Pfizer Sanford, NC Quality Assurance Compliance department by performing Quality Assurance activities associated with clinical and/or commercial production. Key responsibilities include interpreting current Good Practices (cGxP) regulations/guidelines and Pfizer Quality Standards to ensure that the site remains compliant within these requirements through of the site self-assessment program (SSA) by conducting internal system audits and walkthrough audits, ensuring placement and approval of audit corrective/preventive actions, assisting with Inspection Readiness activities, and suggesting/implementing continuous improvement activities.

The individual should be able to demonstrate the following independently or as part of a team:
  • A broad depth of knowledge of cGxPs (including Good Manufacturing Practices, Good Laboratory Practices, Good Documentation Practices and Good Clinical Practices)
  • Decision making regarding adequacy and accuracy of documentation and systems to meet regulatory requirements and timely elevation of noted errors, inconsistencies, or deficiencies to appropriate management.
  • Ability to resolve complex issues with minimal assistance from management.
  • Ability to make sound decisions that may involve complex quality and technical issues.
  • Collaboration with a wide range of co-workers, customers and management to gather the input and background knowledge needed to complete assignments.
  • Ability to train colleagues on workgroup practices within area of expertise.
  • Ability to provide guidance/coaching to less experienced colleagues.
  • Ability to identify and implement continuous improvements or new processes and programs.
  • Ability to manage workload to meet established timelines.
  • Individual should have knowledge of US, EU, and ROW cGxP regulations, Microsoft Office™ applications specifically Word and PowerPoint; Lean Six Sigma concepts; and Quality Risk Management.
  • Preferred experience with; Laboratory Information Management System (LIMS); Global Quality Tracking System (TrackWise application); Systems, Applications, and Products (SAP) and Document Management System (PDOCS).


ROLE RESPONSIBILITIES
  • Plan and perform Site Self Assessments through internal system and walkthrough audits, write reports, and follow-up on responses and corrective/preventive actions.
  • Assist site departments with improvement projects as they relate to inspection readiness and as identified during Site Self Assessments.
  • Provide guidance/coaching during audits and Corrective Action/Preventative Action (CAPA) planning.
  • Remain up-to-date on current Regulatory trends (Regulatory Observations, New Regulations/Guidelines) as well as Pfizer Quality Standards.
  • Assist with supplier/vendor audits as needed.
  • Support and prepare site for audits and regulatory inspections.
  • Perform other Quality Compliance functions as needed.


BASIC QUALIFICATIONS
  • BS/BA Degree in Science/related field with 3-5 years of manufacturing, laboratory, quality, technical or engineering experience within biotech or pharmaceutical industry required; OR
  • MS Degree in Science/related field with 0-3 years of manufacturing, laboratory, quality, technical or engineering experience in the biotech or pharmaceutical industry required.


PREFERRED QUALIFICATIONS
  • ASQ Certification
  • Experience in an aseptic manufacturing facility
  • Strong knowledge and understanding of Code of US Federal Regulations Parts 11, 210, 211 and EU Annex 1, Annex 2


PHYSICAL/MENTAL REQUIREMENTS
  • Ability to stand for 3-4 hours at a time, sit for 2 to 3 hours at a time, walk long distances and bend to obtain items from lower shelving/cabinets.


NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
  • Work schedule is primarily first shift during weekdays but may include weekends and second, and/or third shift hours on occasion for assigned tasks/activities including extended hours during Board of Health inspections.
  • Limited travel for the position; no more than 15% traveling.
  • It will be necessary to audit in manufacturing areas that require aseptic gowning.


Other Job Details:
  • Last Date to Apply for Job: November 4, 2020
  • Eligible for Relocation Package
  • Eligible for Employee Referral Bonus
  • #LI-PFE


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