Quality Assurance Senior Associate

Employer
Pfizer
Location
Chapel Hill, North Carolina
Posted
Sep 30, 2021
Ref
4825524
Required Education
Bachelors Degree
Position Type
Full time

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 be a member of Pfizer’s dedicated and highly effective quality assurance team. You will evaluate and review Pfizer’s clinical batches of drugs. You will make sure that product and process documents match the specifications based on established sampling and statistical process control procedures. Your expertise will help in identifying deviations from established standards, in the manufacturing and packaging of products. In the relevant cases you will approve investigations and change control activities to ensure compliance with configuration management 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 focus that will make Pfizer ready to achieve new milestones and help patients across the globe.

How You Will Achieve It

  • Contribute to the completion of projects, manage own time to meet agreed targets and develop plans for work activities on own projects within a team.

  • Suggest improvements and conduct continuous improvement activities.

  • Investigate, document Quality Assurance related deviations and escalate issues as appropriate to the Quality Assurance Lead in a timely manner.

  • Support GMP Active Library including file upkeep, true copy verification, document check in/out, and quarterly review.

  • Quality Shop Floor program. Spend 20-50% of time on manufacturing floor performing real time review of MBR/SBR, provide quality oversight and support of manufacturing processing steps.

  • Maintain regulatory compliance in accordance with current Good Manufacturing Practices {part of GxP} practices.

  • Provide Quality Review and oversight of site cGxP documentation related to the operation of a multi host/multi product manufacturing facility/laboratory to ensure compliance with global regulatory agencies and Pfizer quality standards.

  • Accurately communicate Supply/Operational needs/perspectives as well as Quality Operations (QO) perspectives.

  • Review and approval of validation documents Process, cleaning & method validation.

  • Review and approve master batch records and executed batch records to assure compliance with regulatory standards and regulatory filing.

Qualifications

Must-Have

  • Bachelor's Degree

  • 3+ years' experience

  • Experience in Quality administered systems

  • Knowledge of current Good Manufacturing Practices and the applicable GxP regulations and standards

  • Proactive approach and strong critical thinking skills

  • Must be able to work in a team environment within own team and interdepartmental teams

  • Excellent communication and interpersonal skills

  • Good working knowledge of Microsoft Excel and Word

Nice-to-Have

  • Master's degree and relevant pharmaceutical experience

  • Willing to lead by example and jump right in, desire to get to root cause, collaborative and active listener

  • Effectively manages stressful situations, able to focus on task at regardless of circumstances and stress induced pressure

  
 

PHYSICAL/MENTAL REQUIREMENTS

Mental agility to handle a broad scope of different types of quality assurance work (e.g. reviewing documentation focus, communication 1:1 and with larger groups).  Ability to independently problem solve and make recommendations for solutions.  Role is primarily office-sitting, standing, walking, and bending.  This may be inclusive of leading/participating in Webex.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Standard 40-hour workday

20%+ time spent on the shop floor

Other Job Details:

  • Last Date to Apply: October 14th, 2021

  • Eligible for Employee Referral Bonus

Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment.  As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.

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’s 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.

Quality Assurance and Control

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