Position Summary
· Manages personnel and provides oversight of the Environmental Monitoring activities and program.
· Ensures the completion of EM portions of projects and processes included equipment/process changes (E/Ps), excursions, EMPQs, Risk Assessments, and other special projects.
· Assist Microbiology Management with investigations of environmental excursions.
· Performs other duties as assigned or apparent.
Primary Accountabilities:
NOTE: The primary accountabilities below are intended to describe the general content of and requirements of this position and are not intended to be an exhaustive statement of duties. Incumbents may perform all or most of the primary accountabilities listed below. Specific tasks or responsibilities will be documented in the incumbents’ performance objectives as outlined by the incumbents’ immediate supervisor or manager.
· Ensures staff training is complete and current.
· Coordinate daily activities to monitor environment, air quality and personnel samples in production area. Assists in daily review of aseptic monitoring technicians’ data entry and paperwork, as needed.
· Provides review and approval of initiated reports, EMPQs, protocols, summary reports, trending reports, excursions, quality events, and other materials, as required.
· Manages EM approvals in TrackWise Digital for documents, batch records, materials, and E/Ps.
· Manages all personnel responsible for document review, investigations, EMPQs, and other special projects to ensure completion.
· Oversees and coordinates sampling program for facility WFI.
· Provides support for personnel during Environmental Monitoring/Personnel Monitoring excursion investigations; assists in implementation of corrective actions.
· Performs employee performance evaluations and training
· Monitors employee time to ensure attendance policies are upheld.
· Assist in Media fills validations as needed
Knowledge, Skills & Abilities:
· Regionally accredited BS Degree with 7 years Pharmaceutical or related industry experience preferred.
· Experience in general computer operation; various levels of experience with Non-Viable Particulate Counter, Viable Air Sampler, and aseptic gowning.
· Demonstrated experience following cGMP and regulatory requirements.
· Experience with USP Guidelines, cGMP, Aseptic Processing, Aseptic Environmental Monitoring Techniques, and Microbiological quality control testing.
· Highly organized, with great written and oral communication skills.
· Specific expertise, skills, and knowledge within Microbiology gained through education and experience.
· Excellent communication and documentation skills; able to communicate issues, updates, and priority change effectively.
· Flexible and open to receive and provide training in other areas.
· Must have strong organizational skills and be able to manage multiple projects or assignments at one time.
· Specific expertise, skills and knowledge within microbiology gained through education and experience.
· The ability and willingness to change direction and focus to meet shifting organizational and business demands.
· The ability to create and contribute to a work environment that values people, encourages trust, teamwork, and open communication, and provides participation, learning, feedback and recognition.
· The ability to effectively manage one self, demonstrates integrity, be productive under pressure, and achieve development goals.
· The ability to take strategic objectives and accept accountability to drive results through effective actions
· Position requires bending, typing, lifting (up to 20lbs), reaching, vision, standing (30%), sitting (40%), walking (30%), talking and hearing.
· Position encounters the following environmental factors: heat, water, hazardous materials including biohazardous waste, laboratory chemicals and other non-specified hazardous materials that are project specific.
· Incumbents are required to wear safety glasses, hearing protection, PPE Gowning, and other non-specified protective equipment as necessary.
· Salary range: Based on experience
