Job Description

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

You will help us in investigation of our quality issues in manufacturing and quality laboratories. You will investigate deviations and out-of-specification results and atypical result investigations. Your problem-solving skills will help to identify root cause and suggest appropriate corrective action plan. Your attention to detail will help us ensure that the reports are aligned to regulatory requirements and company policies.

As a Senior Associate, your knowledge and skills will contribute towards the goals and objectives of the team. 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 QC investigations team in Quality Control department at the Rocky Mount site. The position leads investigations as the responsible person, coordinates CAPA, and drives to on time closure of investigations.

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.

ROLE RESPONSIBILITIES
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
• 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

Qualifications

• Applicant must have a High School Diploma (or Equivalent) and 8 years of relevant experience OR an associates degree with 6 years of experience OR a bachelors with at least 3 years of experience OR Masters with more than 1 year of experience.

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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.
• Drafting written investigations to assure clear, concise summaries, product impact assessments, and commitments
• Ability to receive feedback from management and other colleagues, takes accountability for actions and personal development
• Support regulatory and internal audits through the preparation, defense 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
• Consistently adheres to company, site, and laboratory safety rules and immediately raises any safety issues with management as soon as they are identified.
• Follows procedures at all times, adopting cGMP, cGDP practices.
• Possesses technical competencies of analytical techniques, such as non-instrumental wet chemistry techniques, Manual Titrations, pH, Conductivity, Autotitrations, UV-Vis, Polarimeter as wells as more advanced techniques, such as GC, HPLC, AA, FTIR, ICP-MS, etc.
• Has familiarity with package components test and requirements.
• Has general understanding of manufacturing processes and documentation.
• Provides guidance for investigational strategy; reviews and approves investigational protocols and reports; ensures correct root cause identifications and implementation of appropriate CAPAs
• Tracks and trends investigational metrics.

PHYSICAL/MENTAL REQUIREMENTS

Stand up for up to 4 hours, sit for up to 8 hours, walking, climbing stairs, responding to visual warning indicators, respond to audible warning indicators, respond to color or special visual indicators, wear specialized protective clothing (lab coat, safety glasses, gloves, face shield/goggles, apron), repetitive use of upper extremities.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

There are no out of the ordinary travel or shift requirements associated with the position. Individual will be expected to work nonstandard schedule as needed to support the business objectives

Work Location Assignment: Flexible

*Job Details: \xc2\xb7 Last Date to Apply for Job: , 2023

\xc2\xb7 Eligible for Employee Referral Bonus: Yes

\xc2\xb7 Schedule:

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

Sunshine Act

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider\xe2\x80\x99s name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

EEO & Employment Eligibility

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

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