Shift Leader - Environmental Monitoring Job at Pfizer (Rocky Mount)

Job Description

The Shift Team Leader, Environmental Monitoring (EM) will be responsible for the smooth running of the labs across their shift and in addition to ensuring a consistent approach is executed across all analysts on the shift. This position will be tasked with the managing the lab budget supplies and shift staffing level to ensure impact to Operation in minimized and sampling is performed per procedures. This position will be responsible for working with Ops and site quality team to ensure shift resources are properly allocated and prioritized relative to Operations daily needs. In addition, this position will be responsible for the optimization of lab operation and ensure the smooth implementation of IMEX for their shift of responsibility.

Job Responsibility

Responsible for the smooth running of the labs across their shift
Ensuring a consistent approach is executed across all analysts on the shift
Managing the lab budget supplies and shift staffing level to ensure impact to Operation in minimized and sampling is performed per procedures
Working with Ops and site quality team to ensure shift resources are properly allocated and prioritized relative to Operations daily needs
Responsible for the optimization of lab operation and ensure the smooth implementation of IMEX for their shift of responsibility
Ensure all investigations and CAPAs are thoroughly completed to prevent repeat occurrences
Appropriate and timely sample reconciliation in sample management systems including but not limited to MODA, gLIMS, EAMS etc
Assisting the EM Leader and EC Leader in ensuring quality standards are met and product impact is minimized
Supervise and train personnel in related areas
Supports/maintains employee safety training programs for the Environmental Control (EC) areas of responsibilities
Ensures all pertinent specifications and SOPs are updated and audited as needed to assure continuous compliance
Supervises the daily activities of the Lab Analysts in EM areas
Controls and resolves personnel issues within the EM workplace and enforces HR policies
Comply with site wide procedures including but not limited to change control, documentation, deviation reporting, cGMP, compliance, safety, and electronic data security
Responsibilities may include hire, train, and evaluate employees
Monitor the performance of staff via metrics such that corporate and business goals are met
Must be able to aseptically gown, spend time on the shop floor to ensure continuous dialog with Operation to minimize quality impact on batches

Requirements

Applicant must have a bachelor's degree with at least 2 years of experience
OR a master's degree with more than 0+ years of experience
OR an associate's degree with 6 years of experience
OR a high school diploma (or equivalent) and 8 years of relevant experience
Experience in a lab operation in a pharmaceutical setting
Requires strong oral, written, communication, presentation, and interpersonal skills
The incumbent must have a minimum 1+ years EM operation and 6 months of supervisor experience directly or indirectly, preferable in aseptic manufacturing environment/lab operation
Requires thorough/working knowledge of GMP’s, PICS, USP and ISO with expertise in sterile processing
Must have demonstrated ability to handle multiple projects in a dynamic environment/lab setting
Must have knowledge of regulatory guidance and industry standards and apply to corporate and divisional guidelines
must be able work in a stressful environment, be able to make decision when needed or required to escalate following company policies and requirements
Should be able to carry as heavy as 35 pound weight
Clearly understanding of cGMP and sterile manufacturing is a must have
Flexibly in work and availability during public holidays are expected
This position requires permanent work authorization in the United States

Nice to have

Work with aseptic training team to develop necessary training for colleagues working in the EM lab
Maintaining working knowledge of cGMPs and emerging regulatory and compliance concerns as related to sterile manufacturing and lab operation
Support EM analysts on the shop floor to ensure they are properly equipped and trained on necessary policies and procedures

What we offer

Eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 10,0% of the base salary
401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution
paid vacation, holiday and personal days
paid caregiver/parental and medical leave
health benefits to include medical, prescription drug, dental and vision coverage
Relocation assistance may be available based on business needs and/or eligibility

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Shift Leader - Environmental Monitoring

Job Description

Job Responsibility

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