Lead Investigator

Description

Use Your Power for Purpose

Every day, everything we do is driven by an unwavering commitment to delivering safe and effective products to patients. Our quality culture, which is both science and risk-based, is designed to be flexible, innovative, and customer-oriented. Whether your role involves development, maintenance, compliance, or analysis through research programs, your contribution is crucial and will have a direct impact on patients.

 

What You Will Achieve

In this role, you will:

•    Investigate quality issues within manufacturing and quality laboratories utilizing Method 1 DMAIC tools (fishbone diagrams, 5 whys, process mapping) as needed to perform root cause analysis.
•    Investigate manufacturing deviations, out-of-specification results, and atypical results
•    Use your problem-solving skills to identify root causes and suggest effective corrective action plans
•    Interact and coordinate with appropriate personnel including internal departments, outside vendors, bacterial/viral development QA, regulatory (US/Japan/EU/China), and Qualified Persons during the investigation process
•    Facilitate cross-functional and cross-site team meetings to perform a thorough investigation. Able to identify root cause, present complex problems with possible solutions, and actively take a leadership role to resolve investigation-related issues. 
•    Assess the impact of events on products, equipment, or processes. Communicate with management for all discrepancies that may impact product, and delay disposition or shipments.
•    Propose solutions to identified problems, determine corrective actions and continuous improvements, and assign commitments to facilitate implementation of solutions.
•    Track, trend, and evaluate previous events and assess CAPA effectiveness and impact to current investigation.
•    Draft investigation reports using strong technical writing skills to assure clear, concise summaries, product impact assessments, and related commitments.
•    Collaborate with QA to close investigations and assign responsibility for CAPA commitments.
•    Receive feedback from management and other colleagues, take accountability for actions and personal development.
•    Support regulatory and internal audits by being able to discuss and defend previous investigations.
•    Have a strong understanding of cGMP, Data Integrity and ALCOA principles.
•    Execute and manage multiple initiatives at the same time; use good communication skills to provide updates on investigation status to area management.
•    Ensure all reports comply with regulatory requirements and company policies
•    Contribute to moderately complex projects, managing your own time to meet targets
•    Develop plans for short-term work activities within a collaborative team environment
•    Apply skills and discipline knowledge to contribute to work within the Work Team
•    Work under general supervision, following established procedures and general instructions

 

Here Is What You Need (Minimum Requirements)

•    BA/BS with at least 2 years of experience or MBA/MS with any years of experience or associate's degree with at least 6 years of experience or high school diploma (or equivalent) with at least 8 years of relevant experience
•    Proven record of problem-solving and decision-making skills
•    Experience in the pharmaceutical industry
•    Strong background and knowledge in manufacturing, compliance, and technology investigations, processes, and systems
•    Ability to work both independently and collaboratively
•    Effective communication skills, both written and verbal
•    Computer literate with superior skills in managing Excel spreadsheets

 

Bonus Points If You Have (Preferred Requirements)

•    Master's degree
•    Experience with investigations, including conducting and writing investigations
•    Knowledge and experience in Six Sigma and Lean methodologies
•    Familiarity with regulatory requirements and quality standards
•    Experience with FDA and EU licensing and inspection
•    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)
•    Strong analytical and critical thinking skills
•    Ability to manage multiple projects simultaneously
•    Experience with root cause analysis and corrective action plans
•    Excellent organizational skills
•    Ability to mentor and guide junior colleagues
•    Strong interpersonal skills and the ability to foster a collaborative team environment
 

 PHYSICAL/MENTAL REQUIREMENTS

• Position requirements are typical for an office-based work environment with some shop floor exposure. 

• Perform mathematical calculations and ability to perform complex data analysis

 

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

 

• Schedule is primarily day shift (M-F, 8 hrs) but may require off-shift work on occasions.

• The position requires 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.

Work Location Assignment: On Premise

Relocation Assistance: No

 

 

The annual base salary for this position ranges from $80,300.00 to $133,900.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 10.0% of the base salary. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site – U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.

 

 

 

 

Relocation assistance may be available based on business needs and/or eligibility.