Nature and Scope
The QC Environmental Monitoring Lead works with Environmental Monitoring (EM) team in the activities associated with the manufacture of sterile pharmaceuticals in accordance with company Standard Operating Procedures, cGMPs and all other company policies. The EM Lead with interphase with EM Supervisor and EM Team to ensure the necessary support required by production areas is provided. The EM Lead will help Supervisor to oversee the environmental monitoring program and will provide training, guidance, and support to EM team under Supervision. The Lead will coordinate scheduling of EM team and provide input and assistance to EM Supervisor and other departments as needed.
Essential Duties and Responsibilities
Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.
Under the direction of the EM Supervisor oversee the environmental monitoring program and EM team.
Lead and support gown qualification and gown training of other staff members, where applicable.
Support EM Supervisor to provide technical and administrative support for all activities related to environmental monitoring, and documentation.
Appropriately schedule EM workload to meet department/site requirements under Supervision.
Schedule employees with respect to workload to improve efficiency for EM and Water Sampling.
As required assist EM team in sampling and other environmental monitoring responsibilities.
Use TrackWise/Veeva to initiate change controls and review SOP’s as necessary, recommend changes, updates and as needed.
Assists Environmental Monitoring Supervisor to ensure EM team for their respective shift are current on all training requirements.
Review EM Worksheets/LIMS for accuracy and completeness and submit to Microbiology laboratory.
Using TrackWise- Issue and perform investigations, deviations or event reports, CAPA and ensure the closure, in a timely manner.
Ensure all tasks are completed for their respective shift and convey any discrepancies to Environmental Monitoring Supervisor.
Ensure all changes within Production Schedule are conveyed across all shifts.
Track the inventory of the media and material 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 EM Supervisor with timely completion of quarterly and other periodic projects and reports.
Perform any other tasks/duties as assigned by management.
Education Requirements and Qualifications
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.
High School Diploma or GED equivalent with minimum of 4 years’ experience in a pharmaceutical aseptic processing environment, medical device, beverage, or food microbiology industry required; or Associate Degree in microbiology, biology or related scientific field with minimum of 2 years’ experience in a pharmaceutical aseptic processing environment, medical device, beverage, or food microbiology industry required; or Bachelor’s degree in a science or related field with 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. Previous experience in performing PQ of new EM and water systems is preferred.
Experience with operation of instruments like Met One, air ideal, SAS, MAS 100, MAS 100 CG, Lighthouse System, or PMS system is 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.
Must be able to maintain Class 100 Certification for EM support.
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 in 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. PPE and Respirators are essential for the health and safety of employees.
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.
Expected Hourly Rate:
$32.94 - $35.00
The hourly rate displayed is the minimum and maximum hourly rate of compensation for the role that the employer in good faith believes to be accurate at the time of the posting of an advertisement for the role. Actual compensation for the role will be based on a number of different factors including but not limited to the candidate’s qualifications, education, knowledge, skills and experience.
American Regent also offers a competitive total rewards package which includes healthcare, life insurance, profit sharing, paid time off, matching 401k as well as a wide range of other benefits.
American Regent celebrates diversity and we are 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.
American Regent Inc. endeavors to make https://americanregent.com/Careers accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email hrtalentacquisition@americanregent.com.
