{"schemaVersion":"jobsearcher.job.v1","id":"bc2578036bdbfe5b0d9b2267","url":"https://jobsearcher.com/jobs/bc2578036bdbfe5b0d9b2267","canonicalUrl":"https://jobsearcher.com/jobs/bc2578036bdbfe5b0d9b2267","title":"Quality Operations Specialist","description":"tendersglobal.netWhy Patients Need YouEverything 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 AchieveYou 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 ItEnsure overall compliance of Clinical and Commercial products for all regionsEnsure post-release surveillance commitments are met, including participation in product complaint investigations, Biological Product Deviation Reporting, Field Alerts, and RecallsSupport product launch activities for introduction of product into new countriesAssure 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 ProgramsParticipate in Regulatory inspectionsEnsure label requirements for each country are definedParticipate in Material Review Board meetings as neededProvide administrative support for Material Review Board meetings, such as schedule and facilitate meetings, scribe, and distribute meeting minutes, and draft executive summariesParticipate in investigations to support timely regulatory actions and communication when warrantedSupport Product Recall team, participating in investigations to determine product impact and distribution, and lead for quality operations communication to impacted partiesSupport Quality Agreement negotiations with vendors or partners to Seattle GeneticsDevelop 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 marketsAssess current business processes for the team, and identify opportunities for continuous improvement to drive efficiency, scalability, and risk reductionInfluence cross-functional teams to meet compliance and business needsQualificationsMust-HaveBachelors 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 experienceExperience in Quality administered systemsKnowledge of current Good Manufacturing Practices and the applicable GxP regulations and standardsProactive approach and strong critical thinking skillsMust be able to work in a team environment within own team and interdepartmental teamsExcellent communication and interpersonal skillsGood working knowledge of Microsoft Excel and WordNice-to-HaveRelevant pharmaceutical experienceWilling to lead by example and jump right in, desire to get to root cause, collaborative and active listenerEffectively manages stressful situations, able to focus on task at regardless of circumstances and stress induced pressurePhysical/Mental RequirementsAbility to work effectively and efficientlyAbility to multitask without loss of efficiency or accuracyAbility to complete assigned tasks without direct supervisionAbility to exercise independent judgment and make decisionsOther Job DetailsLast day to apply: March 20th, 2024Relocation support availableWork 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 tendersglobal.net (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 ActPfizer 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 EligibilityPfizer 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 ControlJ-18808-Ljbffr","company":"Pfizer","rawCompany":"pfizer","city":"Bothell","state":"WA","isRemote":false,"isActive":false,"createdAt":"2026-05-30T03:38:38.094Z","occupations":[{"code":"11-3051.01","title":"Quality Control Systems Managers","slug":"quality-control-systems-managers"},{"code":"19-4099.01","title":"Quality Control Analysts","slug":"quality-control-analysts"},{"code":"13-1041.07","title":"Regulatory Affairs Specialists","slug":"regulatory-affairs-specialists"}],"industries":[{"code":"325412","title":"Pharmaceutical Preparation Manufacturing","slug":"pharmaceutical-preparation-manufacturing"},{"code":"325414","title":"Biological Product (except Diagnostic) Manufacturing","slug":"biological-product-except-diagnostic-manufacturing"},{"code":"541714","title":"Research and Development in Biotechnology (except Nanobiotechnology)","slug":"research-and-development-in-biotechnology-except-nanobiotechnology"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Quality Operations Specialist","description":"tendersglobal.netWhy Patients Need YouEverything 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 AchieveYou 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 ItEnsure overall compliance of Clinical and Commercial products for all regionsEnsure post-release surveillance commitments are met, including participation in product complaint investigations, Biological Product Deviation Reporting, Field Alerts, and RecallsSupport product launch activities for introduction of product into new countriesAssure 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 ProgramsParticipate in Regulatory inspectionsEnsure label requirements for each country are definedParticipate in Material Review Board meetings as neededProvide administrative support for Material Review Board meetings, such as schedule and facilitate meetings, scribe, and distribute meeting minutes, and draft executive summariesParticipate in investigations to support timely regulatory actions and communication when warrantedSupport Product Recall team, participating in investigations to determine product impact and distribution, and lead for quality operations communication to impacted partiesSupport Quality Agreement negotiations with vendors or partners to Seattle GeneticsDevelop 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 marketsAssess current business processes for the team, and identify opportunities for continuous improvement to drive efficiency, scalability, and risk reductionInfluence cross-functional teams to meet compliance and business needsQualificationsMust-HaveBachelors 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 experienceExperience in Quality administered systemsKnowledge of current Good Manufacturing Practices and the applicable GxP regulations and standardsProactive approach and strong critical thinking skillsMust be able to work in a team environment within own team and interdepartmental teamsExcellent communication and interpersonal skillsGood working knowledge of Microsoft Excel and WordNice-to-HaveRelevant pharmaceutical experienceWilling to lead by example and jump right in, desire to get to root cause, collaborative and active listenerEffectively manages stressful situations, able to focus on task at regardless of circumstances and stress induced pressurePhysical/Mental RequirementsAbility to work effectively and efficientlyAbility to multitask without loss of efficiency or accuracyAbility to complete assigned tasks without direct supervisionAbility to exercise independent judgment and make decisionsOther Job DetailsLast day to apply: March 20th, 2024Relocation support availableWork 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 tendersglobal.net (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 ActPfizer 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 EligibilityPfizer 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 ControlJ-18808-Ljbffr","datePosted":"2026-05-30T03:38:38.094Z","dateModified":"2026-05-30T03:38:38.094Z","hiringOrganization":{"@type":"Organization","name":"Pfizer","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Bothell","addressRegion":"WA","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"bc2578036bdbfe5b0d9b2267"},"url":"https://jobsearcher.com/jobs/bc2578036bdbfe5b0d9b2267"}}