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 

The position will be responsible for managing a team of 6-8 FTE's and completing investigations in the site investigations electronic system as part of the centralized investigations team in the Technical Operations department at the Sanford site.  The position leads complex investigations as the responsible person, coordinates CAPA, and drives to on time closure of investigations.  The position also must also provide leadership, training, and coaching for junior investigators in the group. 

The candidate should be detail-oriented, able to execute work independently with strong organizational and communication skills, able to work with various groups across the organization, and be able to utilize Method 1, Pfizer Human Performance, and operational excellence tools and techniques.

In addition, knowledge of other electronic systems used at the site including PDOCs, LIMS, SAP, PLS, EAMS, MS Word, MS Powerpoint and MS Excel is required as part of the job. 

How You Will Achieve It

Responsibilities include the following:

• Perform investigations for manufacturing, engineering and maintenance, QA, QC, supply chain, and technical operations related deviations including:

  • Utilizing Method 1 DMAIC tools (fishbone diagrams, 5 whys, process mapping) and Pfizer Human Performance tools 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 and reviews to resolve investigation issues. Ability to identify issues, present complex problems with possible solutions, and actively takes leadership role to resolve issues

  • Assessing the impact of events on products, equipment, or processes, communicating with management for all discrepancies that may impact product, and recommending disposition

  • 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 written investigations to assure clear, concise summaries, product impact assessments, and commitments

  • Collaborating with QA to close investigations and to assign commitments for CAPAs

  • Ability to receive feedback from management and other colleagues, takes accountability for actions and personal development

• Support regulatory and internal audits through the preparation, defence and interaction with auditors for requested 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 keep customers, peers, and area management up-to-date with progress of all such efforts

• Provide leadership, training, and coaching for junior investigators within the group

• Be recognized as an SME for the site investigations electronic system (currently QTS, will be Veeva Vault)

• Identify and lead continuous improvement initiatives for the investigation process

• Represent Site Investigations on site or network teams as necessary

BASIC QUALIFICATIONS

• Applicant must have a High School Diploma (or Equivalent) and 10 years of relevant experience OR an associates degree with 8 years of experience OR a bachelors with at least 5 years of experience OR Masters Degree with more than 3 years of experience, OR a PhD with 0+ years of experience.

PREFERRED QUALIFICATIONS

• Direct knowledge and experience in 6 Sigma and Lean methodologies and relevant experience in a biopharmaceutical or pharmaceutical cGMP environment is required. 

• Experience with completing investigations within a quality tracking system is required.

• Experience with FDA and EU licensing and inspection is preferred.

• Experience with project management is desired. 

• 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 MS Word, MS Powerpoint and MS Excel are required.

PHYSICAL/MENTAL REQUIREMENTS

Position requirements are typical for an office-based work environment with some shop floor exposure.  There are no unusual physical or mental requirements for this position.

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.  Overtime may periodically be required. The position may require working on the floor in manufacturing, laboratory, or utility areas at times which will require a focus on safety. Aseptic gowning could be required. 

Other Job Details:

• Last Date to Apply for Job: April 10th, 2023

• Work Location Assignment: Onsite

• ​Relocation Support Available

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