Investigations and Compliance Specialist

Employer
Pfizer
Location
Saint Louis, Missouri
Salary
Competitive
Closing date
Jul 5, 2022

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Sector
Pharmaceutical, Regulatory Affairs
Hours
Full Time
Organization Type
Corporate
Jobseeker Type
Professional
Why Patients Need You

Pfizer's purpose is to deliver breakthroughs that change patients' lives. Research and Development is at the heart of fulfilling Pfizer's purpose as we work to translate advanced science and technologies into the therapies and vaccines that matter most. Whether you are in the discovery sciences, ensuring drug safety and efficacy or supporting clinical trials, you will apply cutting edge design and process development capabilities to accelerate and bring the best in class medicines to patients around the world.

What You Will Achieve

As a Senior Associate Scientist, Investigations and Compliance Specialist, you will be at the center of our operations and you'll find that everything we do, every day, is in line with an unwavering commitment to quality. Your significant experience of applying knowledge of principles, concepts, and practices of the discipline will make you a critical member of the team.

The qualified candidate will join the Analytical R&D (ARD) Microbiology Strategy and Testing (MST) organization to enable development of biological therapeutics. The Senior Associate Scientist, Investigations and Compliance Specialist, will be accountable for MST laboratory/manufacturing investigations and providing compliance support for the MST laboratories across BTx, including the Andover, MA; Chesterfield, MO; and Durham, NC locations. The candidate will help ensure c ompliance with cGMP microbiological regulations, Pfizer Quality Standards (PQS's), and provide audit support. This individual will be expected to develop collaborative relationships with Quality Assurance (QA), manufacturing Operations, and other supporting groups, in order to facilitate investigations using continuous improvement techniques. The incumbent will be expected to have working knowledge of GMP's, experience with laboratory operations, and various microbiological testing techniques (including Environmental Monitoring).

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

How You Will Achieve It

  • Author high quality and timely investigations within the Pfizer quality systems (i.e. QTS)
  • Ensure investigations are conducted with a strict adherence to appropriate quality and compliance standards
  • Support internal and external audits, including coordination of audit requests and responses
  • Author Pfizer PQS compliance assessments
  • Regularly and proactively review compendia and regulatory requirements, addressing any gaps and ensuring compliance
  • Represent MST on internal Compliance Forums and Quality Councils
  • Analyze data from investigations and inspections to identify, recommend, and implement improvements. Promote adherence to root cause analysis and human error reduction tools


Qualifications

Must Have
  • 3-6 years Bachelor's Degree in microbiology, molecular biology, biochemistry, or related field
  • 2-4 years of experience in a GMP microbiology laboratory
  • Must be able to interact effectively with peers and leaders as part of a cross-site, multi-disciplinary team
  • Experience with GMP investigation processes
  • Advanced technical writing skills


Nice To Have
  • Ability to self-manage timelines and deliverables
  • Strong organizational skills with demonstrated attention to detail
  • Experience with laboratory data systems such as Laboratory Information Management Systems (LIMS), QTS, and GDMS
  • Ability to thrive in a dynamic environment


PHYSICAL/MENTAL REQUIREMENTS

Position requires periods of standing, sitting, or walking.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Some occasional travel to other Pfizer sites or industry conferences is possible.

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.

Research and Development

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