Operations Investigator

Employer
Pfizer
Location
Rocky Mount, North Carolina, United States
Posted
Oct 30, 2020
Ref
4795771
Required Education
Associate Degree
Position Type
Full time
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. 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

The Operations Investigator is responsible for completing investigations and providing documented evidence of root cause and Corrective Actions and Preventative Actions (CAPA) for plant quality issues. This individual will work closely with colleagues at multiple levels within the organization in order to achieve timely completion of investigations.
  • Conduct and write formal investigation reports, collaborating with plant colleagues.
  • Frequently enters the production area wearing appropriate gowning as necessary, to collaborate with colleagues and gather information for each investigation.
  • Perform impact risk assessment; assist in root cause determination.
  • Prior investigation writing experience (with determination of product impact).
  • Plans appropriate corrective action and preventative action (CAPA).
  • Perform reviews and evaluate sensitive, confidential information and develops recommendations for use by the plant quality assurance department.
  • Defining and recommending corrective and/or preventive actions identified through the investigation process.
  • Facilitates strategy meetings.
  • Presents information to colleagues and site leadership as needed.


Qualifications

Must-Have
  • Bachelor's Degree required.
  • 2-5 years of experience in a manufacturing environment required.
  • Prior experience utilizing various investigation tools (5 Whys, Fishbone, 6 Ms, 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.
  • Strong problem solving skills.
  • 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
  • Scientific/Technical field of study preferred.
  • Prior work experience in pharmaceutical or FDA regulated quality environment strongly preferred.
  • Pharmaceutical operations experience and/or knowledge preferred.


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
  • This shift is primarily day shift, Monday - Friday. Flexibility to work outside of regularly scheduled work hours may be required to support business needs.


Other Job Details:
  • Eligible for Relocation Package
  • Eligible for Employee Referral Bonus
  • #LI-PFE


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