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QA Manager, ADC Operations

Employer
Pfizer
Location
Pearl River, New York
Start date
Aug 5, 2022
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Job Details

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 critical member of the site’s dedicated and highly effective Quality Operations Team, the QA Manager, ADC Operations will be responsible for providing quality assurance support to Manufacturing and Testing Operations relative to the production of commercial and/or clinical products.

The QA manager will 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.

In addition, the QA manager will 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.

How You Will Achieve It
  • Review batch records and perform disposition of commercial and clinical trial materials
  • 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)
  • Fosters a culture of continuous improvement
Qualifications

Must-Have
  • Applicant must have a High School Diploma (or Equivalent) and 10 years of relevant experience OR an associates degree with 8 years of experience OR a bachelors with at least 5 years of experience OR Masters Degree with more than 3 years of experience, OR a PhD with 0+ years of experience.
  • Pharmaceutical manufacturing/Quality experience
  • Knowledge of GMP regulations/guidances (21 CFR Parts 11, 210 &211; EC Annex 15; ICH 7) as they pertain to the pharmaceutical/biopharmaceutical industry.
  • A team player with strong interpersonal, organizational, and communications skills are a must. Additionally, the candidate must be self-motivated, engaged and able to perform moderately complex tasks independently.
Nice-to-Have
  • A broad understanding of Biopharmaceutical Sciences processes an
  • Proficiency with basic business analysis tools such as process mapping, decision flowcharting, DMAIC, etc.)
  • Excellent communication skills including technical writing and presentation development and delivery
  • Proficient in data integrity principles and management of electronic records
  • Advanced computer skills in MS Office applications and good knowledge of enterprise systems, such as PDM, Quality Tracking System Trackwise, Documentum platforms


PHYSICAL/MENTAL REQUIREMENTS

  • This position will spend significant time in an office type setting.
  • Position will also support on the floor activities such as AQL sampling, gowning, event troubleshooting, etc.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

  • May require support for site as needed beyond core business hours.
  • Little to no travel required.


Work Location Assignment:On Premise

Other Job Details:
• Last Date to Apply for Job: August 22, 2022

• Eligible for Relocation Package: No
• Eligible for Employee Referral Bonus: Yes
#LI-PFE

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

#LI-PFE

Company

Join world-class scientists and leaders who are dedicated to bringing therapies that will significantly improve patients' lives.

As one of the world's premier innovative biopharmaceutical companies, we're driven to discover the cure --driven to significantly improve the lives of everyone...everywhere. If you're similarly driven, you'll find there's no better place to begin --and continue --your career than at Pfizer.

Science is the foundation of our company.  This is why it's no surprise that the most driven scientists in the world choose to carry out their life's passion at Pfizer.  We arm them with the resources, technology, and facilities they need to solve some of the world’s most complex health challenges. This combination empowers our scientists with expertise in vaccines, small-molecule medicines, biotherapeutics amongst many others, to collaborate on breakthrough science, including the world's first mRNA-Based Covid19 vaccine.  Our colleagues advance science and technologies into the therapies that matter most.

Join us and you'll partner with colleagues of diverse backgrounds and abilities who contribute to all aspects of what we do. Great things happen when people come together with one shared goal. If you're driven to discover the cure- ensure it has the latest technology to make it a reality or help improve the lives of others- join those who are similarly driven at Pfizer. The future of medicine is happening here.

Visit www.pfizer.com and connect with us.

 

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Find Us
Website
Phone
(212) 733-2323
Location
235 East 42nd Street
New York, NY 10017
United States
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