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
You will help us in investigation of our quality issues in manufacturing and quality laboratories. You will investigate deviations and out-of-specification results and atypical result investigations. Your problem solving skills will help to identify root cause and suggest appropriate corrective action plan. Your attention to detail will help us ensure that the reports are aligned to regulatory requirements and company policies.
The Quality Investigations Approver is responsible for reviewing and approving quality investigations (QARs, Events, LIRs and RAACs) and associated documentation (Interim reports, corrective and preventive actions). The Quality Investigation Approver is responsible for assessing potentially impacted product to ensure it meets cGMP and regulatory requirements to assure safety, identity, strength and quality. The Quality Investigation Approver provides guidance on impacted product disposition based on the investigation. He/she is responsible for assuring that investigations are written in accordance with site requirements and are robust, stand-alone documents based on logic and the appropriate use of investigational tools.
It is your hard work and commitment that will help in making Pfizer ready to achieve new milestones and help patients across the globe.
How You Will Achieve It
- Review, provide comments, and disposition investigation documentation.
- Provide guidance identifying potential product impact and determine final product disposition through report approval.
- Provide guidance on remediation and developing corrective and preventive action (CAPA) plans.
- Lead the review and approval of Investigations by collaborating with peers in other departments.
- Lead the successful closure of CAPAs through collaboration with peers in operations and other departments.
- Function as a quality representative as needed supporting the reduction of event initiation and continuous improvements of the system of quality investigations.
- Provide real-time guidance on event classification and proper actions to mitigate and limit potential product impact.
- Assist with internal, third party, and Federal/State audits, including FDA audits, as applicable.
- Perform special assessments and assignments as required.
- Manage investigations and apply relevant and necessary actions/ systems to ensure appropriate levels of compliance.
Qualifications
Must-Have
- Applicant must have High School Diploma (or Equivalent) with eight years of relevant experience;
- OR an Associate's degree with six years of experience;
- OR a Bachelor’s degree with at least three years of experience;
- OR a Master’s degree with more than one year of experience.
- Professional experience in Quality or Operations, in a cGMP facility.
- Demonstrated quality mind-set and knowledge of Quality Management Systems.
- Experience with investigations, including conducting and writing investigations, using DMAIC methodology
- Demonstrated experience with cGMP and all applicable regulations associated with the manufacturing of sterile parenteral.
- Strong administrative and communication skills are required, verbal and written.
- Effective leadership skills, the ability to manage multiple competing priorities, multitask and work efficiently in a dynamic, ever changing manufacturing environment.
- Computer literate, with skills in managing Excel spreadsheets
Nice-to-Have
- Prior on-the-floor manufacturing experience and/or quality investigator experience with both aseptic and terminally sterilized products is preferred.
- Yellow Belt or Green Belt in Lean - Six Sigma
PHYSICAL/MENTAL REQUIREMENTS
The Quality Investigations Approver position may require lifting, sitting, standing, walking, bending, ability to perform mathematical calculations and ability to perform complex data analysis. The incumbent may be required to stand up for periods of up to 4 hours, use a computer for up to 8 hours and walk up and down stairs.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
The Quality Investigations Approver position may require some extended workdays and weekend work to ensure the review and approval of quality investigations in accordance with pre-established performance metrics and/or agreed upon schedules. He/She is required to adhere to all safety policies and procedures along with cGMP, regulatory requirements, internal Standard Operating Procedures (SOPs) and Pfizer policies and standards. Travel for this position is minimal to none.
Relocation support available: Yes
Work Location Assignment: Onsite
Last date to apply: 4/20/2023
Relocation assistance may be available based on business needs and/or eligibility.
Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.
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.
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