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Pfizer QC Scientist III, Lead Investigator in Andover, Massachusetts

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

The Andover Quality Control Microbiology group is looking for an individual to fill a QC Scientist III, Lead Investigator position within the department. The candidate will be responsible for performing thorough, detailed and timely investigations and generation of high quality and timely investigation reports utilizing advanced technical writing skills. Duties of this position may also include coaching and mentoring to staff members, support for audits, trending of department investigations and continuous improvement activities.

The candidate will be responsible for performing thorough, detailed and timely investigations related to laboratory operations and for the generation of high-quality laboratory related investigation reports.

This individual will be expected to develop collaborative relationships with the laboratory, quality, and other supporting groups in order to facilitate investigations using continuous improvement techniques. The incumbent will be expected to have experience in the area of quality and compliance and a working knowledge of GMPs. Experience with and in depth understanding of laboratory operations and various microbiological testing techniques is required. The candidate will be expected to work with a cross-functional team in defining and improving the approach towards tools used for investigations to meet changing business needs.

It is your knowledge and skills that will help in making Pfizer ready to achieve new milestones and help patients across the globe.

How You Will Achieve It

  • Contribute to achievement of goals at the work group/ project team level as a full team participant.

  • Provide subject matter expertise for standard operating procedures and quality standards content, as well as providing gap analysis to ensure that the environmental monitoring program is compliant with all regulatory requirements.

  • Support change controls, investigations and other technical documents.

  • Initiate and complete investigations to support team activities and resolve procedural deviations.

  • Ensure investigations are conducted with a strict adherence to appropriate quality and compliance standards

  • Interpret guidance/regulations and their applicability to unconventional situations.

  • Work under limited supervision after appropriate training, with the ability to problem solve, manage priorities, and make decisions independently.

  • Support internal and external audits, regulatory queries, and/or network related initiatives as related to investigators.

  • Contribute to a continuous improvement culture within the group using continuous improvement tool

  • Promote adherence to root cause analysis and human error reduction tools

Qualifications

Must-Have

  • Bachelor's Degree in Biology, Microbiology, Chemistry, or related scientific discipline.

  • 6+ years' experience

  • Extensive knowledge and practical application of relevant microbiology (bioburden, endotoxin, etc.) techniques, cGMPS, and regulatory guidance.

  • Strong technical writing skills, including investigations, CAPAs, and/or root cause analysis.

  • Ability to receive feedback and takes accountability for actions and personal development

  • Excellent communication and interpersonal skills

  • Basic computer skills, such as data entry, with a high level of attention to detail, are also required

Nice-to-Have

  • Experience with standard work, 5S, or Six Sigma methodologies

  • Experience leading continuous improvement projects

  • Experience speaking to laboratory practices in regulatory audits

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Occasional off hours coverage may be required depending on needs of the team or scope/status of open investigations.

Work Location Assignment:Flexible

Last Date to Apply: December 2 2022

Relocation assistance may be available based on business needs and/or eligibility.

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

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