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Microbial Control Associate

Pfizer


Location:
Sanford, NC
Date:
02/06/2018
2018-02-062018-03-09
Pfizer
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Job Details

**ROLE SUMMARY**



The position will support the Pfizer Sanford, NC Quality Operations department by performing Quality activities associated with Microbial Control of the Sanford facility. Key responsibilities are supporting investigations, reporting on microflora present in the facility, and researching and implementing new environmental monitoring technologies.







For grade level 4, at a minimum, the individual should be able to demonstrate the following:







+ Demonstrate increasing depth of knowledge within own work area and begin to understand other cross functional areas.



+ Able to develop and execute protocols for the Microbial Control Strategy, including investigational testing, rapid environmental monitoring technologies, etc.



+ Utilize method 1, yellow belt tools to address simple problems and continuous improvement ideas under limited guidance/coaching. Knowledge of basic QRM principles. Completes basic tasks with minimal oversight.



+ Act as an individual contributor, and be open and accepting of own personal areas for development. Acceptance that coaching and mentoring for own development will originate not only from people leader, but from other colleagues.



+ Trains less experienced colleagues as appropriate.



+ Makes decisions that require knowledge of quality systems.



+ Develop problem solving skills for technical issues.



+ Recognize when issues require more information and escalates issues appropriately and in a timely manner.



+ Recognizes the impact of procedural changes that may impact future quality tasks and decisions.



+ Able to understand ones quality influence on a specific task.



+ Able to identify when there is a non-conformance and bring it to one's manager.



+ Work is accurate with little or no errors. Sound decisions are made on simple work.



+ Applies discipline's principles and appropriate procedures to design and execute work against work group goals.



+ Able to review working instructions for technical content within own subject area and reference to applicable cGXPs and regulatory expectations, make value-added comments. Influence and negotiate with business line regarding content with limited guidance/coaching.



+ Responsible for personal delivery of timelines and would seek advice from others for conflicts in priorities.



+ Shares information obtained from interaction with business lines at immediate team meetings.



+ Completes tasks assigned by a Quality project representative. Established interpersonal skills (building confidence in presentations and be able to respond to questions) needed to operate in a team environment within work area.



+ Manage workload to meet established timelines.



+ Increased ability to communication effectively using various tools and techniques. Using visual aids as needed (e.g. SOP). Able to effectively communicate and establish relationships within Quality lines.







Individual should have knowledge of current US, EU, and ROW cGXP; Quality systems; Microsoft Office applications specifically Word and PowerPoint; Lean Six Sigma concepts; and Quality Risk Management. Preferred experience with Laboratory Information Management System (LIMS).







**ROLE RESPONSIBILITIES**







+ Responsible for knowing, understanding, role modeling, and ensuring others Responsible for knowing, understanding and acting in accordance with cGXP Pfizer's values and our OWNIT culture



+ Provides report outs to manufacturing regarding applicable EM data



+ Provides environmental and utility investigational support



+ Write and execute protocols applicable to microbial control strategy



+ Assessment/validation of new rapid environmental monitoring technology



+ Monitor low level recovery from classified manufacturing areas, generate report for Microbial Control Strategy Manager



+ Responsible for coordination of disinfectant effectiveness studies with contract labs as applicable



+ Generate SOPs for new equipment







**QUALIFICATIONS**



Requirements for Grade level 4:







+ 2-4 years of manufacturing, quality or engineering experience in the biotech or pharmaceutical industry.



+ A BS/BA Degree in Science/related field with experience in biotech or pharmaceutical industry is preferred; however, other appropriate combinations of education and/or experience in the biotech or pharmaceutical industry are suitable.







**PHYSICAL/MENTAL REQUIREMENTS**



Ability to lift 30 lbs., stand for 2 to 3 hours at a time, sit for 2 to 3 hours at a time, walk long distances and bend to obtain items from lower shelving/cabinets







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



Primarily M-F during standard business hours; however, required work schedule may include weekdays and/or weekend days with first, second, and/or third shift hours as appropriate for assigned tasks/activities.



Limited travel for the position; no more than 5% traveling.







**OTHER INFORMATION**







+ Relocation assistance eligible, but not a full relocation package







**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.







**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.







**Last Date to Apply for Job:** 16 February, 2018







Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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