Aaas Bothell , WA 98021
Posted 2 months ago
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 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
Ensure overall compliance of Clinical and Commercial products for all regions
Ensure post-release surveillance commitments are met, including participation in product complaint investigations, Biological Product Deviation Reporting, Field Alerts, and Recalls
Support product launch activities for introduction of product into new countries
Assure compliance of products released to distribution and market, including Regulatory compliance check to Product Specification File, Filings, etc.
Assure compliance of products released for use in Investigator Sponsored Trials and Patient Access Programs
Participate in Regulatory inspections
Ensure label requirements for each country are defined
Participate in Material Review Board meetings as needed
Provide administrative support for Material Review Board meetings, such as schedule and facilitate meetings, scribe, and distribute meeting minutes, and draft executive summaries
Participate in investigations to support timely regulatory actions and communication when warranted
Support Product Recall team, participating in investigations to determine product impact and distribution, and lead for quality operations communication to impacted parties
Support Quality Agreement negotiations with vendors or partners to Seattle Genetics
Develop knowledge on regulatory requirements in United States and Canada, where product is actively distributed for both Clinical and Commercial use, as well as potential future markets
Assess current business processes for the team, and identify opportunities for continuous improvement to drive efficiency, scalability, and risk reduction
Influence cross-functional teams to meet compliance and business needs
Qualifications
Must-Have
Bachelors Degree with at least 3 years of experience OR Masters with more than 1 year of experience OR High School Diploma (or Equivalent) and 8 years of relevant experience OR an Associates Degree with 6 years of 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
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 work effectively and efficiently
Ability to multitask without loss of efficiency or accuracy
Ability to complete assigned tasks without direct supervision
Ability to exercise independent judgment and make decisions
Other Job Details:
Last day to apply: March 20th, 2024
Relocation support available
Work Location Assignment:Flexible (Required to be On Premise an average of 2.5 days per week)
The annual base salary for this position ranges from $78,000.00 to $130,000.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 10.0% of the base salary. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site - U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.
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'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. This position requires permanent work authorization in the United States.
Quality Assurance and Control
Aaas