Senior Associate, Quality Assurance

Employer
Pfizer
Location
Sanford, North Carolina
Posted
May 13, 2022
Ref
4839626
Required Education
Associate 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.

Supports the Pfizer Sanford, NC Quality Operations department by performing Quality Assurance activities associated with clinical and/or commercial products. Acts as Quality Risk Management (QRM) system owner and Annual Product Records Reviews (APRRs) program Lead. Key responsibilities are managing the QRM program, leading the APRR efforts, performing Quality final authorization/approval/release of cGXP documentation and process; project management of and executing complex projects; suggesting improvements and conducting continuous improvement activities; and providing guidance/coaching to less experienced colleagues.

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 and commercial 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
  • Responsible for knowing, understanding, and acting in accordance with cGXPs, Pfizer’s values and our OWNIT culture.
  • Providing Quality Review/Oversight of site cGXP documentation related to the operation of a vaccine manufacturing facility/laboratory to ensure compliance with global regulatory agencies and Pfizer quality standards.
  • Responsible for project managing QRM program and risk register.
  • Responsible for Quarterly updates and report outs of Quality system health to the Site Quality Review Team.
  • Responsible for setting up strategy and schedule for APRRs and delivering reports on time. Ensures that site strategy is aligned with network deliverables.
  • Responsible for final authorization/approval/release of documentation.
  • Assessing existing situations and suggesting improvements in the Quality systems to increase compliance throughout the facility.
  • Plans and leads projects to ensure their timely completion with project management tools.
  • Provide guidance/coaching to less experienced colleagues.
  • Organizes and provides written and/or oral presentations of work with minimal input.
  • Effectively summarizes and present information to broad audience.
  • Contributes to the interpretation of cGXPs for the commercial and clinical environment.
  • Independently reviews working instructions/global procedures for technical content across multiple subject areas, with reference to applicable cGXPs and regulatory expectations make value-added comments. Interfaces with other parts of the organization such as Pfizer research and development groups. Able to work outside immediate subject area, supporting a wider range of customers of differing subject areas and locations.
  • Reviews trending reports and influences /agrees actions with key stakeholders.
  • Interprets and understands complex data and forms conclusions and next steps based on findings with minimal assistance from management.
  • Makes decisions and demonstrates sound judgment when involved with complex quality and technical issues.
  • Makes decisions that may impact project progression and timelines.
  • Expertise with leading and approving investigations of complex technical issues and able to independently handle investigations across cross-functional work areas.
  • Anticipates issues and elevates them to appropriate management attention immediately.
  • Support Regulatory inspections and compliance initiatives.
  • Able to assess internal and external compliance with applicable regulations.
  • Proactively and independently applies departmental best practices to work assignments.
  • Able to recognize when such a multi-disciplinary discussion/issue is beyond their sphere of influence and escalates accordingly.
  • Manage workload to meet established timelines.
  • Coach/mentor other colleagues with QRM, APRRs, and investigations
Qualifications

Must-Have
  • Associates Degree with 5+ years experience
  • Bachelors Degree with 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

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 primarily first shift during weekdays but may include weekends and second, and/or third shift hours on occasion for assigned tasks/activities including extended hours during Board of Health inspections.

Other Job Details:

  • Last Date to Apply:March 16th, 2022

  • Eligible for Employee Referral Bonus

  • Not Eligible for Relocation Assistance

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