Shire Jobs

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 an 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 Microbiology Strategy and Testing organization to enable development of biological therapeutics and will be accountable for MST laboratory/manufacturing investigations and providing compliance support for the MST laboratories across BTx, including the Andover, MA and Chesterfield, MO locations. The candidate will help ensure compliance with cGMP microbiological regulations, Pfizer Quality Standards, 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 GMPs, experience with laboratory operations, and various microbiological testing techniques including Environmental Monitoring. It is your innovative scientific temperament that will help make Pfizer ready to achieve new milestones and help patients across the globe.

How You Will Achieve It

• Contribute to achievement of immediate work group goals and collaborate with other team members

• Author high quality and timely investigations within the Pfizer quality systems (i.e. eQMS)

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

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

• Support internal and external audits, including coordination of audit requests and responses

• Author PQS compliance assessments

• Regularly and proactively review compendia and regulatory requirements, addressing any gaps and ensuring compliance

• Represent MST at internal Compliance Forums and Quality Councils

• Analyze data from investigations and inspections to identify, recommend, and implement improvements

Qualifications

Must Have

• Bachelor's Degree: microbiology, molecular biology, biochemistry, or related field

• 3-6 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 LIMS, eQMS, and GDMS

• Ability to thrive in a dynamic environment

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

• Some travel to other Pfizer sites or conferences is possible.

Other Job Details:

• Last Date to Apply for Job: 11 JULY 2024

• Eligible for Referral Bonus.

Work Location Assignment:Flexible

Flexible colleagues are assigned a Pfizer site within a commutable distance where they work about 2-3 days weekly to connect and innovate with their team face-to-face. However, they also benefit from being able to work offsite regularly when it makes business sense to do so.

The annual base salary for this position ranges from $64,600.00 to $107,600.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 7.5% 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 | (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.

Research and Development