Location: Phoenix, Arizona, United States
The Manager Environmental Control is responsible for managing the technical activities and personnel in the QC Microbiology Environmental control group as they perform routine and non routine Environmental Monitoring of Classified areas, Aseptic Area personnel, and Critical Utilities. The incumbent manages, plans, trains and provides routine and highly advanced technical support related to all environmental monitoring aspects associated with sterile drug manufacturing and microbiological control of the site’s classified areas.
• Carry out responsibilities independently in accordance with the organization’s policies, procedures, and state, federal and local laws.
• Ensure compliance with current Good Manufacturing Procedures (cGMP), USP, EU and other regulatory requirements at all times.
• Ensure compliance with all Company policies and procedures, including safety rules.
• Ensure the site and department objectives are met.
• Ensure employees are properly trained and qualified to perform assigned tasks, provide performance evaluations and support career development of direct reports.
• Ensure all procedures comply with applicable regulatory requirements.
• Manage the site environmental monitoring programs and procedures.
• Manage and provide oversight for special project work associated with Environmental Control and controlled Manufacturing areas.
• Review and approve data generated by Environmental Control Supervisors and Microbiologists.
• Represent QC Microbiology Environmental Control at cross functional team meetings.
• Interact routinely with Manufacturing, Validation and Maintenance Management responsible for Aseptic Processing to ensure best aseptic practices and to resolve issues related to environmental excursions and/or Aseptic Processing.
• Manage Environmental Control related Deviation Investigations and Corrective Actions.
• Train and mentor subordinates, analysts, and other department Supervisors.
• Manage the site Aseptic Technique training and Gown qualification programs.
• Act as Subject Matter Expect for site Aseptic Process Validation Program.
• Serve as author and/or technical reviewer of department operating procedures.
• Manage preparation of written monthly/yearly Environmental Monitoring trend reports. Prepare protocol, summary, document change and investigational reports as needed.
• Participate in interviewing and hiring, performance reviews, coaching, and employee corrective and disciplinary measures when warranted.
• Utilize scientific principles to assist in troubleshooting and problem solving for environmental monitoring deviations and to support continuous improvement of aseptic processing.
• Act as liaison with other departments.
• Represent the department as a Subject Matter Expert during Regulatory Inspections as well as interact with regulatory agencies to present and defend data.
• Assist with budget preparation, including selection and purchase of capital equipment and acquisition of new technologies
• Perform other duties as assigned.
• Requires a Bachelors degree in Microbiology or related science from an accredited college or university with a minimum of 7-10 years related experience in a regulated laboratory, preferably in a pharmaceutical laboratory environment with at least 8 years direct experience in Aseptic Processing Environmental monitoring.
• An equivalent combination of education, experience and training may substitute.
Requires proficiency in basic MS Word, Outlook, Excel
Requires proficiency in advanced MS PowerPoint, Project, Visio
Requires ability to deal appropriately with regulatory agencies
Requires general knowledge of cGMP, OSHA, DEA, USP and EP
Requires detailed knowledge of cGMP, OSHA, DEA, USP and EP
Requires flexibility and ability to multi-task
Requires strong written and verbal communication skills
Requires strong organizational and time management skills
Requires strong critical reasoning and decision making skills
Requires strong teamwork and facilitation skills
Requires ability to develop others, delegate and motivate
Requires ability to interpret / write general business documents
Requires ability to interpret / write technical documents
Requires ability to interpret / write complex business documents
Requires strong qualitative training skills: responsiveness, enthusiasm, humor, sincerity, honesty, flexibility and tolerance
Requires strong presentation development and delivery skills
Requires ability to solve routine and complex problems
Level of Supervision
Does not require direct supervision
Impact of decisions
Impacts multiple departments
Requires uniform/ PPE to work in a manufacturing, warehouse, or laboratory environment
Requires screening (full physical, partial physical, lift test, etc…)
Requires safety alertness due to work around hazardous equipment and conditions
Requires personnel monitoring due to handling of hazardous substances