Shift Leader - Environmental Monitoring (Night Shift)

Pfizer • Rocky Mount, NC

2d • Onsite

About The Position

Use Your Power for Purpose 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. The incumbent will also be responsible to 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. Responsibilities include assisting the EM Leader and EC Leader in ensuring quality standards are met and product impact is minimized. The incumbent will supervise and train personnel in related areas as well as 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. The incumbent needs to have experience in Environmental Monitoring and/or Microbiological Testing and a working knowledge of the appropriate regulations. Supervises the daily activities of the Lab Analysts in EM areas. Also, 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. The person will perform these and other duties as necessary, the inclusion of which will not alter the basic scope of the position. Monitor the performance of staff via metrics such that corporate and business goals are met. Some metrics which performance will be measured against are, but not limited to: # of investigation per shift, # of missed samples and # of unreconciled samples. The incumbent 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 position is self-directed and requires an appropriate level of education, experience, and confidence to make and act upon decisions that impact the site and larger Pfizer network.
• 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

Nice To Haves

• 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.

Responsibilities

• 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.
• 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.
• Responsible for 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.
• Responsible to 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.
• Responsibilities include 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 as well as 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.
• The incumbent must be able to aseptically gown, spend time on the shop floor to ensure continuous dialog with Operation to minimize quality impact on batches.

Benefits

• a 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees