Description

Rangam is seeking candidates for a Direct Hire role as a Lead Investigator with our client Pfizer, one of the world’s largest pharmaceutical companies. Seeking candidates in Sanford, NC or willing to relocate.

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
You will help with investigation of quality issues in manufacturing and quality laboratories. You will investigate manufacturing deviations, out-of-specification results, and atypical results. Your problem-solving skills will help to identify root cause and suggest an appropriate corrective action plan. Your attention to detail will help ensure that the reports are aligned to regulatory requirements and company policies. Your knowledge and skills will contribute towards the goals and objectives of the team by managing moderately complex projects, along with managing your own time to meet targets. Your focus and ability to meet team targets will help in completing critical deliverables. Your innovative use of communication tools and techniques will facilitate in explaining difficult issues and establishing consensus between teams. It is your hard work and commitment that will help in making Pfizer ready to achieve new milestones and help patients across the globe.

How You Will Achieve It
The position will be responsible for completing investigations in the site investigations electronic system as part of the Vaccines Investigations team as the responsible person, coordinating CAPA and driving to on time closure of investigations. In addition, you will use your knowledge of other electronic systems used at the site including eQMS, PDOCs, gLIMS, SAP, PLA, EAMS, MODA, and MS Office tools.
 

Also, you will:

• Perform investigations for manufacturing related deviations utilizing Method 1 DMAIC tools (fishbone diagrams, 5 whys, process mapping) as needed to perform root cause analysis.

• 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. Ability to identify root cause, present complex problems with possible solutions, and actively take 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.

• Ability to 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.

• 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.

Here Is What You Need (Minimum Requirements)

• Applicant must have a bachelor's degree with at least 2 years of experience; OR a master's degree with 0+ years of experience; OR an associate's degree with 6 years of experience; OR a high school diploma (or equivalent) and 8 years of relevant 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

Bonus Points If You Have (Preferred Requirements)

• Knowledge and experience in Six Sigma and Lean methodologies

• 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

• Excellent organizational skills

• 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. 

• Ability to stand for 1 hour at a time, sit for 2 to 3 hours at a time, walk long distances and bend to obtain items from lower shelving/cabinets.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

• Work schedule is 1st shift, Monday - Friday, may include weekdays and/or weekend days with first, second, and/or third shift hours as appropriate for assigned tasks/activities.

• Travel for this position is minimal to none.

• Aseptic gowning could be required.  

Work Location Assignment: On Premise

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