QC Inspection Readiness Lead
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
In this position, you will be joining our Quality Operations department which performs critical Quality Control activities for commercial and clinical product testing. Through collaboration with supporting Quality Control (QC) Laboratories you will conduct inspection readiness activities to ensure cGMP compliance. Key responsibilities include interpreting cGMP regulations / guidelines and Pfizer Quality Standards to ensure that the quality control laboratory remains compliant within these requirements and ensure compliance through the QC inspection readiness program by providing planning, preparation and guidance for site Board of Health inspections and Pfizer corporate audits and assessments. You may lead/co-lead moderately complex projects, conduct inspection readiness walkthroughs, coordinate inspection and audit corrective/ preventive actions, and suggest/implement continuous improvement activities.
It is your hard work and dedication that will make Pfizer ready to achieve new milestones and help patients across the globe.
How You Will Achieve It
Lead QC laboratory inspection readiness (IR) walkthroughs
Coordinate QC IR activities and SME training with Site Inspection Readiness Lead
Lead network gap assessments for inspection findings and trends for quality control laboratories
Monitor emerging regulatory expectations and compliance education
Assist in response coordination for regulatory inspections and corporate audits/assessments
Plan and execute complex projects; suggest improvement and conduct continuous improvement activities
Assist QC departments with improvement projects as they relate to inspection readiness
Assist with inspections/audits
Perform other QC Lab Compliance functions as needed for business continuity
Remain up to date on current Regulatory trends (Regulatory Observations, New Regulations/Guidelines) as well as Pfizer Quality Standards.
Qualifications
Must-Have
Applicant must have a High School Diploma (or Equivalent) and 10 years of relevant experience OR an associates degree with 8 years of experience OR a bachelors with at least 5 years of experience OR Masters Degree with more than 3 years of experience, OR a PhD with 0+ years of experience.
Laboratory experience in pharmaceutical industry.
Excellent project management skills.
Experience driving critical projects to completion within agreed upon timelines.
Excellent oral, written and interpersonal communication skills.
Nice-to-Have
Master’s degree and relevant pharmaceutical experience.
Experience in regulatory inspections.
Experience leading continuous improvement projects and knowledge of lean manufacturing, six sigma methodologies and statistics.
PHYSICAL/MENTAL REQUIREMENTS
Physical:
- Ability to lift up to 30lbs, stand for 2 to 3 hours at a time, sit for 2 to 3 hours at a time, walk short distances and bend to obtain items from lower shelving/cabinets.
Mental:
- Energy, enthusiasm & capability to drive change
- Passion for continuous improvement
- Excellent leadership, influencing, and interpersonal skills
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
This is primarily a 1st shift position however there will be occasional IR walkthroughs for off shifts including weekend shifts.
Work Location Assignment:On Premise
OTHER JOB DETAILS
- Last Date to Apply for Job: November 18, 2024
- Referral Bonus Eligibility: YES
- Eligible for Relocation Package: Yes
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. This position requires permanent work authorization in the United States.
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.
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