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Microbiologist - Kalamazoo - 49005

Employer
Local Staffing
Location
Kalamazoo, Michigan, US
Salary
Competitive
Closing date
Oct 25, 2021

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Sector
Aquarium / Zoo / Botanical garden
Field
Conservation science
Discipline
Other
Salary Type
Salary
Employment Type
Full time
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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.
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 ensure the microbiological control of aseptic manufacturing areas. You will drive continuous improvement and ensure the high quality and continued supply of life-saving pharmaceuticals to the market.
It is your hard work and focus that will make Pfizer ready to achieve new milestones and help patients across the globe.
HOW YOU WILL ACHIEVE IT
* 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 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.
* Write Standard Operating Procedures (SOPs), technical reports, project plans etc. independently.
* Operates within established HR policies and basic colleague relations guidelines.
* Contributes to the completion of team objectives and assigned project milestones.
* Exercises and builds basic team effectiveness skills, such as commitment, feedback and consensus management, within the work group.
* Writes PQ validation protocol and reports and performs associated data analysis.
* 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} compliant Microbiology laboratories.
* Serves on cross functional teams to represent Quality Control and facilitate communications and activities/projects between Quality Control and site departments and/or Network.
* The candidate will be responsible for individual contributions to achieve team deliverables. May perform work independently, or as an integral member of a team.
QUALIFICATIONS
Must-Have
* Bachelor's of Science (B.S.) Degree in Microbiology, Molecular Biology, Immunology, or other related specialized biological science.
* 3+ years of experience in a similar role within the Pharmaceutical and/or Bio-pharmaceutical Industry (or comparable GLP/GMP Laboratory setting)
* Understanding of aseptic laboratory techniques and quality systems
* Knowledge of personnel monitoring, viable and/or non-viable environmental monitoring during pharmaceutical manufacturing
* Aptitude for good decision making based on procedures, guidance, and experience
* Ability to establish effective relationships within business lines
* Excellent oral, written, and interpersonal communication skills
* Knowledge of Microsoft Office applications; specifically, Word, Excel, and Power Point
* A demonstrated ability to organize time independently, ability to perform several tasks concurrently (ability to multi-task), and ability to meet objectives in a flexible, team-oriented environment
NICE-TO-HAVE
* Experience defending laboratory practices in regulatory or customer 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.
o Basic computer skills, such as data entry with a high level of attention to detail, are required.
o Ability to complete aseptic gowning qualification (Grade B)
o Must be able to tolerate long periods of standing, walking, and/or sitting, as needed to complete job tasks.
o Occasional lifting (less than 35 lbs) and reaching may be required.
o Extended time working at a computer terminal is also required.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Primarily First Shift: Approx. 7AM - 3:30 PM, Monday - Friday
o On-Call, Weekend, and/or Holiday hours may be required in order to meet business and/or customer needs.
o Occasional travel may be required ( OTHER DETAILS
* Last Date to Apply: October 22, 2021
* Eligible for Relocation Package
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
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