Specialist QA (Environmental Monitoring)

Job DescriptionJob DescriptionSUMMARYPerform one or more of the following duties and responsibilities in support of Quality Assurance program under minimal supervision. FUNCTIONS- Review and approve product MPs.- Approve process validation protocols and reports for manufacturing processes.- Request Quality on incident triage team.- Approve Environmental Characterization reports.- Release of sanitary utility systems.- Approve planned incidents.- Represent QA on NPI team.- Lead investigations.- Lead site audits.- Own site quality program procedures.- Designee for QA manager on local CCRB.- Review Risk Assessments.- Support Automation activities.- Support facilities and environmental programs.- Review and approve Work Orders.- Review and approve EMS/BMS alarms.- Approve NC investigations and CAPA records.- Approve change controls.- Provide lot disposition and authorize lots for shipment. EDUCATION-Doctorate OR-Masters + 2 years of directly related experience OR-Bachelors + 4 years of directly related experience OR-Associates + 8 years of directly related experience OR-High school/GED + 10 years of directly related experience.

COMPETENCIES/SKILLS- Project management skills.- Strong organizational skills, including ability to follow assignments through to completion.- Initiate and lead cross functional teams.- Enhanced skills in leading, influencing and negotiating.- Strong knowledge in area of expertise.- Collaborate and coordinate with higher level outside resources.- Strong knowledge of and experience with processes involved in manufacturing and distribution, QA, QAL, validation and process development.- Demonstrate ability to interact with regulatory agencies.- Strong word processing, presentation, database and spreadsheet application skills.- Strong communication (both written and oral), facilitation and presentation skills.- Strong skill in working independently and to effectively interact with various levels.- Advanced data trending and evaluation.- Ability to evaluate compliance issues.- Demonstrate the Values/Leadership Practices. Preferred: Microbiology, Biology or Life Sciences What attributes (i.e. - preferred qualifications) would make this candidate stand out? Knowledge in:• Environmental Monitoring, Microbial Identification (Micro ID), Critical Utilities (CU) monitoring• Sampling monitoring: equipment and techniques• Data trending and evaluation• Microbiological testing methods and standards for clean rooms and controlled environments• Aseptic behavior in manufacturing areas to prevent contamination• Facility cleaning and disinfection• Familiarity with the regulatory requirements and quality standards for environmental monitoring in the pharmaceutical industry: Annex 1, FDA Guidance, ISO-14644-1, USP• Word processing, presentation, database, and spreadsheet application skills (Smartsheets, Microsoft Office: word, power point, and excel)• Ability to use software tools and statistical techniques to visualize, interpret, and report on environmental/CU monitoring data• Ability to analyze trend reports and environmental/CU data to identify areas for improvement• Hands on experience in electronic systems for instance: Documentation platforms such as Veeva, Spotfire, LIMS, Maximo.• Use of artificial intelligence tools such as data analytics and large language models• Strong communication (both written and oral), facilitation and presentation skills.

Fully Bilingual in English and Spanish. Specific responsibilities include but are not limited to:• Supports the AML site GMP buildings Environmental Monitoring Process.• Generates Environmental Monitoring and Critical Utilities trend reports.• Participates and or Leads Risk Assessments to evaluate sampling sites for routine monitoring of GMP areas.• Provides assessments to change control records, deviations, audit processes that need support form the Environmental Control perspective.• Participate in forums such as the Environmental Control Network, Aseptic Council and or Contamination Control Network as assigned.• Attends AML GMP Buildings Quality system forums and or Management Review meetings to present environmental and critical utilities data and recommend actions based on the data evaluation.• Ensures that facilities, equipment, materials, organization, processes, procedures, and products comply with cGMP practices and other applicable regulations.• Supports Continuous Improvement initiatives, programs, and projects.• Collaborates cross functionally as needed to ensure the Quality Management System processes are performed in alignment with established procedures.• Alerts senior management of quality, compliance, supply, and safety risks.• Supports internal/external audits and inspections as needed.