Company: Pfizer Inc.
Location: Rocky Mount
Posted on: November 4, 2019
The Compliance Coordinator coordinates, administers, and implements
the quality systems audit response program for regulatory agencies
and external customers. These activities include the evaluation of
audit observations, development of action plans with area
management, implementation of Corrective Actions/ Preventive
Actions (CAPAs), and associated activities to ensure the
manufacture and distribution of pharmaceutical products are
compliant with FDA regulatory requirements and foreign regulatory
bodies. In addition to activities related to the inspections, the
Compliance Coordinator also supports other areas of focus,
including but not limited to, Site Quality Review Team (SQRT),
Compendial Compliance, Metrics, and Regulatory Observation Network
Assessments (RONAs), and Inspection Readiness.
The job duties may include, but are not limited to, the
- Interfaces with site departments in the coordination of audit
planning and post audit activities; including but not limited to,
fulfilling pre-requests, scheduling staffing support of the
inspection, active participation in the inspection, writing
responses, evaluation of robustness of responses and CAPAs received
from departments and submitting responses to agency/ customer.
- Potential interactions and communications with the regulatory
- Participates in regulatory inspections, assessments and
customer audits, as appropriate. Participates in the development
and delivery of auditor training, andregulatory inspection
- Support of the Commitment Tracking Model of the CAPA Management
system, including Initiator, Responsible Person, and/or Approver of
- Evaluates applicable corrective and preventive action responses
to the audit findings for adequacy and timeliness. Assesses and
approves closure of CAPAs within the CAPA Management system as the
QA Approver for audit gQTS records.
- Reports on weaknesses, ineffective procedures, policy
exceptions and discrepancies and, as needed, recommends appropriate
- Actively participates in continuous improvement initiatives to
align with business strategies.
- As needed, leads or participates in self-audit preparation,
resolution of self-audit findings and liaises with auditing groups
and audit stakeholders through all stages of the audits.
- Maintenance of the management of the Quality Improvement Plan
(QIP) for the site.This includes but not limited to, prepares the
QIP governance presentation for the site on a set frequency,
integrates continuous improvements of the QIP, and lead CAPA Audit
- Support of the Inspection Readiness Program.Prepares the
Inspection Readiness presentations, lead the Inspection Readiness
meetings and responsible for maintenance of follow up actions to
ensure the actions are executed in a timely manner.
- Support of the Compendial Compliance Program
- Support of the following: Site Master File, Site Regulatory
Inspection Plan, State License Program, and Risk Assessment
- Supports the preparation, revision, and implementation of
- Supports all compliance responsibilities.
- Bachelor's Degree required.
- Minimum of 4 years of of related experience in a GMP FDA
regulated work environment, in one or more of the following:
Quality Engineering/Compliance/Regulatory Affairs; Manufacturing/
Technical experience in Pharmaceutical or GxP regulated
- Demonstrated ability to work/contribute in a team-based
environment as a lead and a participant with exceptional
interpersonal skills and demonstrated problem-solving skills.
- Thorough knowledge and understanding of the pharmaceutical
regulations and guidelines, including but not limited to cGMPs,
GLPSs, ICH, USP, FDA and other applicable industry guidelines.
- Strong organizational, presentation, meeting facilitation and
technical writing skills.
- Possess attention to detail and good communication skills as
verbal and written feedback to the site SMEs is required when
reviewing/approving audit responses for completeness and
- Strong computer proficiency skills in MS Office, Word, Excel,
CAPA management system or equivalent.
- ASQ-CQA certification preferred.Certification preferred within
2 years of hire.
- Knowledge of the audit process and the ability to interpret
audit observations and provide guidance in audit responses.
- Internal Lead Auditor certification within 1 year of hire.
- Adherence to safe work practices and procedures by applying
appropriate safety and PPE measures as needed
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
- This role is an 8-hour day shift role, Monday - Friday.
- Must have flexibility to work hours outside of regularly
schedule shift and/or extended hours, especially during health
authority inspections, assessments and audits, to accommodate
ad-hoc assignments on an as needed basis, and to support internal
audits as needed.
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.
Other Job Details:
- Last Date to Apply for Job: 13 NOVEMBER 2019
- Eligible for Relocation Package: YES
- Eligible for Employee Referral Bonus: YES
Pfizer is an equal opportunity employer and complies with all
applicable equal employment opportunity legislation in each
jurisdiction in which it operates.
Keywords: Pfizer Inc., Rocky Mount , Compliance Coordinator, Other , Rocky Mount, North Carolina
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