Lead Investigator

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 req