9 days old

Lead, Environmental Monitoring

Pfizer
Sanford, NC 27330
The position will support the Pfizer Sanford, NC Quality Operations department by supporting Environmental Monitoring (EM) activities associated with clinical and/or commercial facilities, utilities and water systems. Key responsibilities are as following: creating, reviewing, executing, and approving EM associated documentation (e.g. SOPs, validation/qualification protocols, investigations, etc.); provides guidance/coaching; assists with colleague training, scheduling and project-based work; identifies continuous improvement opportunities and leads the implementation; and interfaces with and represents Quality Assurance, Microbial Control in cross-departmental meetings.



The individual is capable of demonstrating the following:



+ acts safely and follows all EH&S safety requirements for site and QC laboratories: leads safety initiatives and encourages others to act safely

+ demonstrated technical knowledge of environmental and utilities sampling

+ assist with EM related findings/observations, deviations, CAPAs

+ excellent effective written and verbal communication and interpersonal skills; established relationships within business lines

+ independently interprets and understands complex data/reports and forms conclusions and proposes next steps based on findings.

+ can interpret metrics to support continuous improvement of quality and the business.

+ independently makes decisions based on technical skills and sound judgement regarding complex quality and technical issues

+ ability to receive feedback and take accountability for actions and personal development

+ aptitude for good decision making based on procedures, guidance, and experience

+ understanding of own area of function and knowledge of other cross functional areas

+ support training of new staff within immediate team; mentoring and coaching junior colleagues

+ experience assisting with investigations to define root cause and assisting with validation protocol non-conformances

+ understands the importance of feedback and receives feedback well from management and other colleagues

+ applies microbial control principles and appropriate procedures to design and execute work against work group goals

+ provide guidance/coaching to colleagues.

+ capable of determining colleague training requirements for setting curricula and assisting with colleague development planning.

+ interacts with business lines and shares information with team; capable of influencing and negotiating with business lines

+ increased ability to communication effectively with good interpersonal skills; establish relationships within Quality lines



Individual should have knowledge of current Good Manufacturing Practices (cGMP), Laboratory Information Management System (LIMS), Microsoft Office applications specifically Word and Excel, and Aseptic Practices.



Preferred candidate will have extensive experience with environmental and utilities sampling best practices and procedures; quality investigations and change management.



**ROLE RESPONSIBILITIES**



Responsible for knowing, understanding, role modeling, and ensuring others follow the Pfizer's values.



Performs and plans the tasks/activities associated with maintaining cGXP compliant Quality Control systems.



+ Support for Pfizer, Sanford Gene Therapy facility startup and environmental performance qualification.

+ Performs tasks associated with maintaining and improving a cGXP compliant EM program.

+ Responsible for creation, review, approval and, as applicable, final authorization of cGXP documentation associated with EM

+ Ensuring adherence to regulatory agency requirements, Pfizer standards, policies, and values.

+ Performs EM data review/approval within Sanford LIMS system

+ Act as EM Subject Matter Expert during quality investigations to support Root Cause Analysis and CAPA development



Serves on cross functional teams to represent Quality Operations and facilitate communications and activities/projects between Quality Operations and site departments.



Responsible for assessing existing situations and suggesting continuous improvements to increase compliance, business effectiveness, and innovation.

Plans and leads complex, business projects to ensure their timely completion.



**BASIC QUALIFICATIONS**



+ 5 - 7 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.



**PREFERRED QUALIFICATIONS**



+ Preferred extensive knowledge of basic microbiology, aseptic practices and environmental and utilities monitoring principles.

+ 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.



**PHYSICAL/MENTAL REQUIREMENTS**

Intellectual capability to perform complex mathematical problems and perform complex data analysis.



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



Schedule will be mostly 5 days a week, from 7:30am to 5pm, but may include weekdays and/or weekend days with first, second, and/or third shift hours as appropriate for assigned tasks/activities. Weekend work may be required.

Limited travel for the position; no more than 10% traveling.



**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.



**Other Job Details**



+ **Last Date to Apply for Job: April 20, 2021**

+ Eligible for Relocation Package: NO

+ Eligible for Employee Referral Bonus: YES

+ \#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



\#LI-PFE

Categories

Posted: 2021-04-07 Expires: 2021-05-07

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Lead, Environmental Monitoring

Pfizer
Sanford, NC 27330

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