What are the responsibilities and job description for the Operations Investigator position at Pfizer?
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.
As an associate, your focus on the job will contribute in achieving project tasks and goals. Through your domain knowledge and commitment, you will create a collaborative team environment for your colleagues.
It is your focus and dedication that will make Pfizer ready to achieve new milestones and help patients across the globe.
How You Will Achieve It
- Contribute to the completion of complex projects, manage own time to meet agreed targets and develop plans for work activities on own projects within a team.
- Perform impact risk assessment as well as assist in root cause determination and plans appropriate corrective action and preventative action.
- Ensure Quality Management System for the investigations department are followed and maintained.
- Conduct and write formal investigation reports with the assistance of plant personnel and oversight from manager.
- Coordinate and direct product disposition in accordance to agreed targets and procedures to meet business needs.
- Conduct or participate in major investigations and as required.
- Drive multiple investigations to closure within a specified timeframe per (SOP) Standard Operational Procedures
Qualifications
Must-Have
- Bachelor's Degree in a Scientific or Technical Discipline with 0 - 2 years of investigative or manufacturing experience.
- Or Associate's Degree in a Scientific or Technical Discipline with 3 - 5 years of investigative or manufacturing experience.
- Experience in a manufacturing environment required.
- Prior experience utilizing various investigation tools (5 Whys, Fishbone, Is-Is Not, DMAIC method, etc.) required.
- Prior experience with technical writing (such as deviations, etc.) required.
- Proficiency with MS Office Suite (specifically Word, Excel, and PowerPoint) required.
- Working knowledge of FDA regulations.
- Strong written and verbal communication skills; ability to effectively communicate with employees at all levels within the organization, including plant colleagues and senior management.
- Excellent facilitation skills and ability to facilitate strategy meetings.
- Ability to effectively organize data, extract key information, and write technical summary reports.
- Nice-to-Have
- Prior work experience in pharmaceutical or FDA regulated quality environment strongly preferred.
- Pharmaceutical operations experience and/or knowledge preferred.
- Strong Technical writing/problem solving skills
- Self-driven/motivated
- Prior investigation writing experience preferred
- Experience within Quality
PHYSICAL/MENTAL REQUIREMENTS
- Sitting, Standing, Walking
- Must be able to work independently
- Ability to gown per requirements of the manufacturing area
- Proactively manages the assigned workload; ability to meet or exceed aggressive completion timelines
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
- Relocation support available
- This shift is primarily day shift, Monday – Friday.
- Flexibility to work outside of regularly scheduled work hours may be required to meet colleagues or facilitate M1s
Last date to apply: April 15th, 2022
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.
