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Senior Specialist, Quality Compliance & Inspection

Company

Pfizer
Address , Sanford, Nc
Employment type FULL_TIME
Salary
Expires 2023-10-03
Posted at 9 months ago
Job Description
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. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.
What You Will Achieve
Support the Pfizer Sanford North, NC Quality Assurance Compliance and Inspection department by performing Quality Assurance activities associated with clinical, commercial, and/or contract production. Interprets current Good X Practices (cGxP) regulations / guidelines and Pfizer Quality Standards to ensure that the site remains compliant within these requirements. Ensures compliance through 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 identifying / implementing continuous improvement activities. Perform a lead role during corporate, third-party, and regulatory audits including scribe, runner, backroom preparation, archivist, etc. as assigned.
How You Will Achieve It
  • Hands-on experience with the management of Quality System Processes such as Deviation, CAPA, and Change Controls.
  • Knowledge of US, EU, and ROW cGxP regulations, Microsoft Office applications, specifically Word and PowerPoint, Lean Six Sigma concepts: and Quality Risk Management.
  • Provide guidance / coaching during audits and CAPA planning.
  • Perform other Quality Compliance functions as needed.
  • Remain up to date on current Regulatory trends (Regulatory Observations, New Regulations / Guidelines) as well as Pfizer Quality Standards.
  • Provides guidance/coaching to less experienced colleagues.
  • Plan and perform Site Self Assessments through internal system and walkthrough audits, write reports, and follow-up on responses and corrective / preventive actions. Provide input on and support site departments on improvement projects as they relate to inspection readiness and as identified during Site Self Assessments.
  • Assist with supplier / vendor audits as needed.
Qualifications
Must-Have:
  • Proficient in Microsoft Office software (Word, Excel, PowerPoint).
  • Manufacturing, Laboratory, quality, technical or engineering experience within biotech of pharmaceutical industry.
  • Ability to work independently and multi-task effectively.
  • Hands-on experience with the management of Quality System Processes such as Deviation, CAPA, and Change Controls required.
  • Demonstrated skills in analysis and problem-solving.
  • Applicant must have Associate’s degree with 5-7 years relevant experience or Bachelor’s degree with 3-5 years relevant experience or Master’s degree with 2-3 years relevant experience.
Nice-to-Have:
  • ASQ or Certified Quality Auditor a plus
  • 5 years of diversified experience in a clinical trial, pharmaceutical or biopharmaceutical manufacturing environment.

Physical/Mental Requirements:
  • While performing the duties of this job the employee is frequently required to sit. The employee is occasionally required to stand, walk, bend, use hands to finger, handle, or feel, reach with hands and arms, stoop, kneel, crouch or crawl, and talk or hear. The vision requirements include close vision and distance vision. Occasionally perform mathematical calculations and ability to perform complex data analysis.
  • The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Non-Standard Work Schedule, Travel, or Environment Requirements:
  • Ability to travel (both domestic and international) up to 10%.
Other Job Details:
  • Work Location Assignment: On Premise
  • Eligible for Relocation Assistance: NO
  • Last day to Apply: July 21st, 2023
Relocation assistance may be available based on business needs and/or eligibility.
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
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