- Responsible for timely review of laboratory data, Standard Operating Procedures (SOPs), Equipment Validations, studies, and other documents related to the Microbiology department, as needed.
- Creates and executes project review plans; ensures timely completion of studies or assigned special projects to meet changing needs, requirements, and deadlines of the Microbiology department.
- Assists with additional work duties or responsibilities as evident or required.
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 timely review of Microbiology laboratory data documented using LabVantage, MODA, or via paperwork.
· Reviews and approves laboratory investigations, protocols, summary reports, and test results for Microbiology.
· Assists with writing laboratory investigations, protocols, and summary reports as needed.
· Updates procedures and assists in coordination of Equipment Process/Change Control (E/P) actions in TrackWise with the Microbiology Change Management Specialist.
· Updates and reviews Standard Operating Procedures (SOPs) for accuracy and completeness.
· Reviews Microbiology documentation in accordance with FDA/USP/CFR Guidance.
· Communicates Microbiology-related observations, issues, problems, discrepancies, and any violation of company policies or procedures to QC Microbiology Manager, Director of Microbiology, and/or Quality Management.
Capable of working in a cGMP environment and responsible for maintaining cGMP data.
Knowledge, Skills & Abilities:
- Bachelor’s degree with 1 year of pharmaceutical experience in Quality Systems preferred.
- 1 – 3 years of experience with MS Word, Excel, PowerPoint.
· 1 – 2 years of project management and coordination experience.
· Strong interpersonal, verbal, and written communication skills; effective organization, multi-tasking, documentation, and problem solving skills.
· Possesses the initiative and follow-through to implement, track, and achieve on-time completion of projects, as assigned by management.
· Team player - must be able to interact with all departments within the company.
· Ability to perform tasks with minimum supervision.
· Specific expertise, skills, and knowledge within Microbiology gained through education and experience.
· The ability to manage a multitude of resources and to be accurate and current with data and information.
· A broad perspective that aligns decisions to organizational objectives, and long-term consequences of day-to-day activities.
· The ability to take strategic objectives and accept accountability to drive results through effective actions.
· The ability and willingness to change direction and focus to meet shifting organizational and business demands.
· Must strive for continuous improvement in all work activities.
· The ability to create and contribute to an environment that values people, encourages trust, teamwork, and open communication, and provides participation, learning, feedback and recognition.
· The ability effectively manage one self, demonstrates integrity, be productive under pressure, and achieve development goals.
· The ability to take strategic objectives and accept accountability, motivate and influence others, think globally, and leverage diversity.
· Incumbents are required to wear specified protective equipment as necessary.
· Position requires lifting (up to 40lbs), vision (20/20), standing (10%), sitting (70%), walking (20%), talking, typing and hearing.
· Salary range: Based on experience
Hours of work: Monday thru Friday on an 8-hour shift, or as needed based on company demand.