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QA Manager, ADC Operations

2 months ago

Pearl River, United States Pfizer 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 As a QA Manager, ADC (Antibody-drug conjugates) Operations, you will be a member of Pfizer's dedicated and highly effective quality assurance team. Responsible for providing quality assurance support to Manufacturing and Testing Operations relative to the production of commercial and/or clinical products. Review batch records; assign disposition (approval, rejection, etc.) to the material produced and incoming raw materials, approve investigations for discrepancies; review, edit, and approve protocols and reports, and author, review, and approve SOPs. Perform shop floor activities such as line clearance and AQL inspections. Review and audit logbooks and other shop floor records. Observe shop floor behavior and coach as required. Manage the Quality Agreement process. Independently execute projects/studies/review and analyze, interpret and present the data. Plan work independently and consult with manager as needed. Incumbent knows and applies fundamental technical and quality concepts, applicable guidelines of the FDA or other regulatory bodies and relevant Pfizer SOPs. Participate in Regulatory inspections, assist in managing the change management system and assure all process or other GMP changes are made utilizing the change management system. It is your problem solving skills that will make Pfizer ready to achieve new milestones and help patients across the globe. How You Will Achieve It Review batch records and perform disposition of commercial and clinical trial materials. Overseeing Shopfloor activities and providing coaching and guidance when needed. Manage incoming material disposition and sampling plans. Manage Quality Agreements process ensuring Quality Agreement requirements are met and meet Pfizer expectations. Assist in management of the Change Control process. Review and approve manufacturing investigations ensuring impact, root cause and corrective actions are appropriate. Conduct quality reviews of SOPs, LABs, Change Notifications (CNs), protocols and reports. Provide guidance, lead/co-lead projects, manage own time to meet objectives. Contribute to Quality Assurance by undertaking a variety of roles or assignments to further develop internal processes. Make decisions that may involve complex quality and technical issues. Participate in internal Good Manufacturing Practices {cGMP} audits and support regulatory inspections or corporate audit activities. Participate as a member of the Aseptic Processing Team (APT) Qualifications Must-Have Applicant must have a High School Diploma (or Equivalent) with 10+ years of relevant experience; OR an Associate's degree with eight years of experience; OR a Bachelor's degree with at least 5+ years of experience; OR a Master's degree with more than three years of experience; OR a Ph.D. with 0+ years of experience. Experience/education in microbiology and aseptic processing Pharmaceutical manufacturing Current Good Manufacturing Practices experience with compliance issues resulting from cGMP deviations or product defects, regulations as related to vendor management programs and other industry quality systems and processes Proactive approach and strong critical thinking skills Strong collaboration, relationship management, and interpersonal skills Excellent written and verbal communication Advanced computer skills in MS Office applications and good knowledge of enterprise systems, such as SAP, LACES/LIMS, Quality Tracking System, Trackwise, and Documentum platforms Nice-to-Have Experience in Quality Systems in pharmaceutical, medical device, or combination product industry Quality experience Knowledge or exposure to and data science PHYSICAL/MENTAL REQUIREMENTS Will require sitting, standing, walking, bending, and the ability to perform mathematical calculations and complex data analysis. Will require gowning for CNC environment. NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS Nonstandard work hours and on call hours as needed. Work Location Assignment:On Premise Last date to apply: 9/30/24 The annual base salary for this position ranges from $93,500.00 to $155,900.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 12.5% of the base salary and eligibility to participate in our share based long term incentive program. 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 #LI-PFE