4 days old

Aseptic Quality Microbiologist (2nd Shift)

Pfizer
McPherson, KS 67460
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  • Jobs Rated
    30th
**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 team.

+ You will evaluate and review Pfizer's clinical and commercial batches of drugs. You will make sure that product and process documents match the specifications based on established sampling and statistical process control procedures.

+ Your expertise will help in identifying deviations from established standards, in the manufacturing and packaging of products. In the relevant cases you will approve investigations and change control activities to ensure compliance with configuration management policies.

+ As a Senior Associate, your knowledge and skills will contribute towards the goals and objectives of the team. Your focus and ability to meet team targets will help in completing critical deliverables. Your innovative use of communication tools and techniques will facilitate in explaining difficult issues and establishing consensus between teams.

+ It is your hard work and focus that will make Pfizer ready to achieve new milestones and help patients across the globe.



**ROLE SUMMARY**



+ Displays technical knowledge of Aseptic Processing.

+ Knowledge of applicable techniques, principles, theories, concepts and Pfizer processes and industry practices/standards.

+ Provides real time quality support for aseptic/microbiological related issues in the aseptic and controlled areas.

+ The colleague will need to effectively work/communicate with key stakeholders and peers to ensure timely resolution of aseptic issues that occur.

+ Capable of writing investigations, performing PHP with colleagues and leading M1 projects.

+ Interprets and evaluates data in terms of accuracy, precision, trends and potential GMP impact and recommends and implements appropriate corrective action where necessary.

+ Evaluates changes in approved aseptic manufacturing facilities and equipment for conformance to microbiological quality standards.

+ Writes microbiological evaluations to support changes to existing facilities/processes and for new facilities/processes.

+ Writes SOPs, qualification protocols, technical reports, project plans, etc. Recognizes atypical data, elevates relevant problems, and implements solutions.

+ Focus on leading/overseeing defined processes. Refers to policies and practices for guidance and follows established procedures.

+ Operates within established HR policies and basic colleague relations guidelines. Contributes to the completion of specific team objectives and assigned project milestones.

+ Knowledge and demonstration of leadership principles.



**How You Will Achieve It**



+ Functions as the subject matter expert for issue resolution regarding events that impact the aseptic and controlled areas and environment.

+ Investigation and documentation of environmental monitoring excursions

+ Conduct Microbiological and Sanitization evaluations on an as needed basis

+ Entering aseptic manufacturing areas to observe activities and conduct investigations.

+ Capable of writing and executing PQ protocols for aseptic facility modifications and new facilities

+ Functions as a lead and coordinating activities to return manufacturing areas to aseptic conditions following plant shutdowns.

+ Monitors aseptic core to ensure continual compliance with cGMP's and facility construction/maintenance requirements.

+ Performs evaluations on personnel and environment in the aseptic core. Provides corrective action when necessary.

+ Uses critical problem-solving skills to provide a holistic assessment of an event and resolution to minimize impact and downtime.



**BASIC QUALIFICATIONS**



**Must-Have**



+ **Education:** Bachelor's Degree in Science preferred (Microbiology, Biology, Biochemistry, Chemistry, Engineering, Pharmacy or related science).

+ **Experience:** 3-5 years of experience in a cGMP environment with a strong working knowledge of a variety of quality systems and processes and at least 2 years working in a clean room environment. The candidate must have demonstrated proficiency in organizational and project management skills and must be able to balance multiple priorities to meet established timelines. The candidate should have experience in at least several of the following: Environmental Testing, Microbiology, Aseptic manufacturing processes, inspection practices, cleaning and sanitization, cGLP/cGMPs, Regulatory (worldwide), deviation investigation, product and process validation.

+ **Communication:** Excellent written and verbal communication skills with the ability to share vision, direction, and data with colleagues across all levels and in a wide range of different work groups including senior leadership and regulatory agencies.

+ **Success in Role:** Strong analytical and problem-solving abilities making risk-based decisions appropriate to the situation and circumstances during non-conformance events. Tactful, persuasive and assertive human relations skills. Effective leader, capable of making decisions using experience along with site process and procedures. Robust interpersonal skills and the ability to handle multiple projects. Perform under short timelines while maintaining high standard of work.



**Nice-to-Have**



+ Master's degree and relevant pharmaceutical experience

+ Willing to lead by example and jump right in, desire to get to root cause, collaborative and active listener

+ Effectively manages stressful situations, able to focus on task at regardless of circumstances and stress induced pressure



**PHYSICAL/MENTAL REQUIREMENTS**



+ The capability to aseptically gown.

+ The capability to focus attention on the colleagues' behaviors that in turn leads to higher than normal performance.

+ Ability to hold self and others accountable and to encourage colleagues to take personal responsibility for their performance / actions.

+ Demonstrated ability of strong self-awareness

+ Knowledge of pharmaceutical manufacturing and regulatory compliance

+ Ability to coach combined with a willingness to develop others and to share ideas

+ Demonstrated aptitude to execute Aseptic techniques to a high degree of proficiency.

+ Expert at providing constructive feedback that leads to positive reinforcement.

+ Must be able to communicate and work well interdepartmentally, as well as, with all plant departments.

+ Must be able to read and write, as well as, follow written and oral instructions.

+ Must be capable of performing data entry into calculators and computers.

+ Must be self-motivated, able to work independently and have a problem-solving mindset.

+ Promote a positive team environment.

+ Perform all tasks in a safe manner.

+ Job duties involve occasional lifting (less than 35 lbs.), reaching, and sitting while working at computer terminal.



**NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS**



+ Must be willing to work beyond the hours typically defined as a 'regular' work day, which may or may not include weekends and holidays

+ Stand for up to 8 to 12 hours depending on assigned area.

+ Personnel monitoring results must meet acceptable levels.

+ Ensure that environmental excursions are kept to an acceptable level.

+ Successful candidate will be required to complete various levels of gowning certification in order to enter and support the manufacturing areas.



**Other Job Details:**



+ Last Date to Apply for Job: April 28, 2020

+ Not Eligible for Relocation Package



\#LI-PFE



**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

Jobs Rated Reports for Biologist

Posted: 2021-06-11 Expires: 2021-07-12
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Aseptic Quality Microbiologist (2nd Shift)

Pfizer
McPherson, KS 67460

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