Microbiologist

Employer
Pfizer
Location
Kalamazoo, Michigan
Posted
Jun 09, 2022
Ref
4856637
Required Education
Bachelors Degree
Position Type
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

You will be a member of Pfizer’s dedicated and highly effective quality assurance and control team. The successful candidate will provide microbiological subject-matter expertise within the department, and drive continuous improvement initiatives in support of viable and non-viable monitoring in classified environments as well as support associated laboratory operations. The successful candidate will be part of a specialized dynamic team that interacts with multiple levels and departments throughout the organization to drive change and ensure the high quality and continued supply of life-saving pharmaceuticals to the market.

How You Will Achieve It

  • The successful candidate will become a subject matter expert on the laboratory operations needed to support viable and non-viable environmental monitoring and qualified utilities testing in a highly regulated and controlled GMP manufacturing environment.

  • The successful candidate will assist in the overall operation of the laboratory including: review and approval of environmental monitoring results, submission of microbial isolates for identification, continuous improvement of current processes and methods, assisting with daily/weekly scheduling of laboratory technicians and contractors, overseeing qualification of new laboratory equipment, ordering lab supplies, evaluation of testing and lab practices against regulatory standards to ensure continued compliance, assisting with deviation investigations and corrective action/preventative action creation and execution, and creation and revision of standard operating procedures.

  • The candidate will be responsible for individual contributions to achieve team deliverables. May perform work independently, or as an integral member of a team.

  • Interacts with other team members in the laboratory, within the Microbiology department, and with colleagues from other departments (Operations, Quality, Maintenance/Engineering, and Regulatory).Perform tasks associated with maintaining Good Manufacturing Practices {also cGMP} compliantMicrobiology laboratories.

  • WritePQ validation protocols and reports and perform associateddata analysis.

  • Operate within established HR policies and basic colleague relations guidelines.

  • Write Standard Operating Procedures (SOPs), technical reports, project plans etc. independently.

  • Contribute to the completion of team objectives and assigned project milestones.

  • Exercise and build basic team effectiveness skills, such as commitment, feedback and consensus management, within the work group.

Qualifications

Must-Have

  • A B.S. Degree in Microbiology, Molecular Biology, Immunology or other related specialized biological science.

  • Experience (3+ years) in a similar role within the Pharmaceutical and/or Bio-Pharmaceutical Industry (or comparable GLP/GMP Laboratory setting).

  • Knowledge of viable and non-viable environmental monitoring during pharmaceutical manufacturing and an understanding of aseptic techniques.

  • Aptitude for good decision making based on procedures, guidance, and experience.

  • Excellent oral, written and interpersonal communication skills.

  • Knowledge of Microsoft Office applications, specifically Word and Excel.

  • A demonstrated ability to organize time independently, be able to perform several tasks concurrently (ability to multi-task), and be able to meet objectives in a flexible, team-oriented environment.

Nice-to-Have

  • Experience defending laboratory practices in regulatory audits is preferred.

  • Experience leading continuous improvement projects is a plus.


PHYSICAL/MENTAL REQUIREMENTS

  • Ability to analyze complex data and evaluate microbiological results is required.

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

  • Ability to complete aseptic gowning qualification

  • Long periods of standing, walking, and/or sitting may be needed.

  • Occasional lifting (less than 35 lbs), and reaching may be required.

  • Extended time working at a computer terminal is also required.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

  • Primarily First Shift: Approx. 7:00 AM – 3:30 PM, 5 days/week

  • On-Call, Weekend, and/or Holiday hours may be required in order to meet business and/or customer needs.

  • Occasional travel may be required (<10%).


Relocation support available

Work Location Assignment:Flexible

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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