Full-Time

Lead Investigator

Posted on 12/4/2024

Pfizer

Pfizer

10,001+ employees

Develops and manufactures vaccines and medicines

Biotechnology
Healthcare

Compensation Overview

$78k - $130kAnnually

+ Bonus

Senior

No H1B Sponsorship

Sanford, NC, USA

Work location is on premise.

Category
Biology Lab & Research
Biology & Biotech
Required Skills
SAP Products
Requirements
  • Applicant must have a High School Diploma (or Equivalent) with 8 years of relevant experience OR an Associate's degree with 6 years of experience OR a Bachelor's with at least 3 years of experience OR Master's with more than 1 year of experience
  • Experience in technical writing
  • Time management and organizational skills
  • Proven record of problem-solving and decision-making skills
  • Background and knowledge in manufacturing, compliance and technology investigations, processes and systems
  • Must be comfortable working both independently and collaboratively
  • Effective communication skills are required, both written and verbal
  • Computer literate
  • Knowledge and experience in Six Sigma and Lean methodologies
  • Relevant experience with cGMP in a biopharmaceutical or pharmaceutical environment.
  • Experience with completing investigations within a quality tracking system (QTS/ eQMS).
  • Experience with FDA and EU licensing and inspection
  • Experience with project management
  • Experience using Documentum systems (such as PDOCS), laboratory information management systems (such as LIMS), learning management systems (such as Plateau, PLS, P2L), inventory management systems (such as SAP), and asset management systems (such as EAMS) are highly desired.
  • Proficiency with Microsoft Office
Responsibilities
  • Completing investigations in the site investigations electronic system as part of the GTx/mAbs Investigations team as the responsible person, coordinating CAPA, and driving to on time closure of investigations.
  • Perform investigations for manufacturing related deviations including utilizing Method 1 DMAIC tools (fishbone diagrams, 5 whys, process mapping) as needed to perform root cause analysis during investigations.
  • Interacting and coordinating with appropriate personnel including internal departments, outside vendors, bacterial/viral development QA, regulatory (US/Japan/EU/China), and Qualified Persons during the investigation process.
  • Facilitating cross-functional and cross-site team meetings to perform a thorough investigation. Ability to identify root cause, present complex problems with possible solutions, and actively take leadership role to resolve investigation-related issues.
  • Assessing the impact of events on products, equipment, or processes. Communicating with management for all discrepancies that may impact product, and delay disposition or shipments.
  • Proposing solutions to identified problems, determining corrective actions and continuous improvements, and assigning commitments to facilitate implementation of solutions.
  • Tracking, trending, and evaluating previous events and assessing CAPA effectiveness and impact to current investigation.
  • Drafting investigation reports using strong technical writing skills to assure clear, concise summaries, product impact assessments, and related commitments.
  • Collaborating with QA to close investigations and assign responsibility for CAPA commitments.
  • Ability to receive feedback from management and other colleagues, takes accountability for actions and personal development.
  • Support regulatory and internal audits by being able to discuss and defend previous investigations.
  • Strong understanding of cGMP, Data Integrity and ALCOA principles.
  • Execution and management of multiple initiatives at the same time and good communication skills to provide updates on investigation status to area management.
  • Manage investigations and apply relevant and necessary actions/ systems to ensure appropriate levels of compliance.

Pfizer is a biopharmaceutical company that focuses on creating and producing healthcare products, including medicines and vaccines. The company conducts extensive research and development to discover new treatments, which are then manufactured and sold to various clients such as governments, healthcare providers, and patients around the world. Pfizer's products include vaccines, oncology treatments, and other specialized medicines. A notable achievement is its partnership with BioNTech to develop a vaccine for COVID-19, which has played a significant role in addressing the pandemic. Pfizer aims to improve public health by ensuring access to vaccines, especially for underserved populations, and continues to grow its product offerings with new approvals and treatments.

Company Stage

IPO

Total Funding

$3.8B

Headquarters

New York City, New York

Founded

N/A

Simplify Jobs

Simplify's Take

What believers are saying

  • Pfizer's significant investments in companies like CellCentric and Caribou Biosciences indicate a strong focus on expanding its oncology and cell therapy capabilities.
  • The company's proactive approach in securing investments and partnerships positions it well for future growth and innovation in the biopharmaceutical sector.
  • Pfizer's involvement in funding rounds for promising biotech firms suggests potential for lucrative returns and strategic advancements in healthcare solutions.

What critics are saying

  • The slowdown in demand for COVID-19 vaccines could impact Pfizer's revenue and market perception.
  • Activist investor involvement, such as Starboard Value's $1 billion stake, may lead to pressure for strategic changes that could affect company stability.

What makes Pfizer unique

  • Pfizer's strategic partnerships and investments in innovative biotech companies like Promise Bio and Enara Bio highlight its commitment to cutting-edge research and development.
  • The company's collaboration with BioNTech for the COVID-19 vaccine showcases its ability to rapidly respond to global health crises, setting it apart from many competitors.
  • Pfizer's diverse portfolio, including oncology and specialized medicines, ensures a broad market reach beyond just vaccines.

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