QC Environmental Monitoring Lead

2 weeks ago

Shirley, New York, United States American Regent, Inc. Full time
Job Summary

The QC Environmental Monitoring Lead will work closely with the Environmental Monitoring team to ensure the quality and integrity of our sterile pharmaceutical products. This role requires strong leadership and technical skills to oversee the environmental monitoring program and provide guidance to the EM team.

Key Responsibilities
  • Oversee the environmental monitoring program and ensure compliance with company Standard Operating Procedures and cGMPs.
  • Lead and support gown qualification and training of EM team members.
  • Provide technical and administrative support for all activities related to environmental monitoring and documentation.
  • Schedule EM workload to meet departmental requirements and ensure efficient use of resources.
  • Assist the EM team in sampling and other environmental monitoring responsibilities.
  • Use TrackWise/Veeva to initiate change controls and review SOPs as necessary.
  • Ensure the EM team is current on all training requirements and review EM worksheets/LIMS for accuracy and completeness.
  • Perform investigations, deviations, or event reports, CAPA, and ensure timely closure.
  • Ensure all tasks are completed for their respective shift and convey any discrepancies to the Environmental Monitoring Supervisor.
  • Track inventory of media and materials required for the Environmental Monitoring program and order supplies as necessary.
  • Closely interact with and support manufacturing and quality personnel in all aspects of Environmental Monitoring.
  • Assist the EM Supervisor with timely completion of quarterly and other periodic projects and reports.
Requirements
  • High School Diploma or GED equivalent required; Associate Degree in microbiology, biology, or related scientific field preferred.
  • Minimum of 4 years' experience in a pharmaceutical aseptic processing environment, medical device, beverage, or food microbiology industry required.
  • Previous experience working in environmental monitoring/sampling, writing EM protocols and EM investigations, water sampling, and leading gown qualification program required.
  • Experience with operation of instruments like Met One, air ideal, SAS, MAS 100, MAS 100 CG, Lighthouse System, or PMS system required.
  • Minimum 2 years of Environmental Monitoring floor experience preferred with consistency on time and task deliverability.
  • Strong understanding of Aseptic Technique, Aseptic Behavior, and Quality Culture.
  • Ability to train and teach EM Team.
  • Trending of EM and Water data.
  • Excellent computer skills and proficient in Microsoft Word, Excel, and Outlook.
  • Excellent communications skills both verbal and written.
  • Needs to be adaptable and maintain the ability to be flexible in an ever-changing and challenging environment.
  • Demonstrate responsibility and accountability working within a multi-disciplinary team environment.
  • Sense of ownership and ability to take responsibility.
  • Skilled understanding of leadership role and able to exhibit leadership qualities.
  • Must be flexible with working hours, dependable, and able to work overtime as needed, according to the production schedule.
Physical Environment and Requirements
  • Physically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves.
  • Specific vision requirements include 20/40 near vision (can be corrected with eyeglasses or contacts) and color vision.
  • Employees must maintain a clean-shaven appearance each working shift to wear tight-fitting respirators properly.
  • Employee must be able to occasionally lift and/or move up to 25 pounds.
  • Job activities require long periods of standing and use of controlled movements as well as aseptic techniques/behaviors in the sterile filling suites.
Compensation

The hourly rate for this role is $35.00. American Regent offers a competitive total rewards package, including healthcare, life insurance, profit sharing, paid time off, matching 401k, and a wide range of other benefits.

American Regent celebrates diversity and is committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status.

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